OT:RR:CTF:EMAIN H337761 MFT
Center Director – Pharmaceuticals, Health and Chemicals C.E.E.
Port of Cincinnati
4243 Olympic Blvd., Suite 210
Erlanger, KY 41018
ATTN: Ms. Leslie Holmes, Supervisory Import Specialist
Re: Application for Further Review of Protest No. 4197-22-105721; Classification of the FL 350 and FL 400 Pulse Oximeters from China
Dear Center Director:
The following is our decision on the Application for Further Review (AFR) of Protest No. 4197-22-105721, which was filed on August 22, 2022, by counsel on behalf of Lorte Technologies, Inc. (Protestant). The protest pertains to U.S. Customs and Border Protection’s (CBP) classification under the Harmonized Tariff Schedule of the United States (HTSUS) of certain pulse oximeters.
FACTS:
The subject merchandise consists of two models of pulse oximeters from China: the “FL 350” and the “FL 400.” These pulse oximeters are designed to readily examine the oxygen saturation of arterial hemoglobin and the pulse rate of patients at home and in clinical environments. The information provided by the pulse oximeters, alone, cannot form the basis for a diagnosis; rather, it must be read together with other clinical information to determine if the blood is well oxygenated.
The internal components of the FL 350 include: a printed circuit board assembly (PCBA); thin film transistor (TFT) screen; LED; sensor; microcontroller unit (MCU); resistor; capacitor; button; and bare printed circuit board (PCB). The external components include an outer shell, a pad that attaches to the finger, a screen protection panel, and springs.
The internal components of the FL 400 consist of: a PCBA; LED screen; LED; sensor; MCU; resistor; capacitor; button; and bare PCB. Its external components include an outer shell, a pad that attaches to the finger, a screen protection panel, and springs. For each device, the MCU includes software for receiving and processing sensor data and producing the output on the screen.
Each pulse oximeter is calibrated to display functional arterial oxygen saturation (SpO2). The pulse oximeters do not require a blood sample from the patient; rather, each device clamps to a user’s finger and measures SpO2 levels and the pulse rate in beats per minute (bpm) via the sensor. The pulse oximeters are not intended for use in laboratory research applications, nor in ambulances or air transport.
Each pulse oximeter operates with an SpO2 accuracy of a root-mean square difference of less than or equal to 4.0% over the range of 70 to 100% of oxygenated hemoglobin (SaO2). To validate its accuracy, each pulse oximeter underwent a controlled desaturation study that involved clinical testing of volunteers and comparing values obtained by the subject oximeters’ SpO2 measurements with those found via secondary standard pulse oximeter equipment. Moreover, each pulse oximeter provides pulse rate data with measurements between 30 bpm to 250 bpm with an accuracy of ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm, and ±2% during the pulse rate range of 100 bpm to 250 bpm. Neither device is equipped with an alarm. If the pulse oximeters fail to register a signal, the device will provide a warning to the operator indicating signal inadequacy.
The subject merchandise was entered between January 14, 2022, and June 22, 2022. The protestant entered the merchandise under heading 9018, HTSUS, specifically subheading 9018.19.95, HTSUS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Other: Other.” CBP liquidated the subject merchandise under primary heading 9029, HTSUS, specifically subheading 9029.20.40, HTSUS, which provides for “Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9018; stroboscopes; parts and accessories thereof: Speedometers and tachometers; stroboscopes: Other speedometers and tachometers.”
In support of its proposed classification, the protestant claims that the subject pulse oximeters “are unambiguously articles ‘used in medical . . . sciences” and presents certain documents from the Food and Drug Administration (FDA). These documents include information from the FDA’s Global Unique Device Identification Database (GUDID), a system that is used “to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use,” as well as FDA registration information. Additionally, the protestant notes that the subject pulse oximeters have obtained 510(k) clearance from the FDA. “This,” the protestant claims, “means that the company [i.e., Lorte Technologies, Inc.] registered and notified the FDA of [Lorte’s] intent to market a medical device, and that based on similar devices on the market, the FDA gave clearance to market [Lorte’s] product as a medical device on the market.”
ISSUE:
Whether the subject pulse oximeters are classified under heading 9018, HTSUS, as “instruments used in medical sciences” or under heading 9029, HTSUS, as “tachometers.”
LAW AND ANALYSIS:
This matter is protestable under 19 U.S.C. § 1514(a)(2) as it regards a CBP decision on classification. This protest was timely filed, within 180 days of liquidation of the first entry. Further review of this protest is properly accorded to the protestant pursuant to 19 C.F.R. § 174.24(a) because the protestant alleges that CBP’s liquidation of the subject pulse oximeters under heading 9029, HTSUS, is inconsistent with its rulings on similar fingertip oximeters. Specifically, the protestant points to New York Ruling Letter (NY) N144735 in which we found that a certain pulse oximeter from China was classifiable under heading 9018, HTSUS.
Classification under the HTSUS is in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods will be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 will then be applied in order.
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are generally indicative of the proper interpretation of the heading.
The HTSUS headings under consideration are as follows:
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof:
* * * * *
9029 Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9018; stroboscopes; parts and accessories thereof.
This matter turns on the application of GRI 1, specifically whether the subject merchandise meets the terms of heading 9018, HTSUS, as “instruments used in medical sciences” or the terms of heading 9029, HTSUS, as a “tachometer.” It is a well-established principle “that statutes, regulations, and administrative interpretations not related to tariff purposes are not determinative of customs classification disputes.” It is also well-established that “in order to produce uniformity in the imposition of duties, the dutiable classification of articles imported must be ascertained by an examination of the imported article itself, in the condition in which it is imported.” If the subject pulse oximeters are described in whole by the terms of one of the headings, then that heading applies, and the succeeding GRIs are inoperative.
Neither the HTSUS nor the ENs define the term “tachometer.” In the absence of a definition of a term in the HTSUS or ENs, the term’s correct meaning is its “common and commercial meaning.” The common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities, and other reliable sources. We previously consulted several standard and medical dictionaries to define the term “tachometer,” finding that the term may encompass articles certain heart rate monitors. As we articulated in Headquarters Ruling Letter (HQ) 087550:
There is ample support for the position that articles which measure pulse and heart rate are specialized types of tachometers described as hemotachometers and cardiotachometers. The Random House Dictionary of the English Language, Random House, Inc. (1973), defines "tachometer" as follows:
1. any of various instruments for measuring or indicating velocity or speed, as of a machine, a river, the blood, etc. . . .
The International Dictionary of Medicine and Biology, John Wiley & Sons (1986), defines "tachometer" as follows:
An instrument that measures speed or rate, such as a cardiotachometer . . .
Stedman's Medical Dictionary, 23rd Ed., Williams & Wilkins Company (1976) defines "tachometer" as follows:
An instrument for measuring the speed or rate of something; e.g., revolutions of a shaft, heart rate (cardiotachometer), arterial blood flow (hemotachometer) . . .
See also Taber's Cyclopedic Medical Dictionary, 14th Ed., F. A. Davis Company (1981); Gould's Medical Dictionary, 5th Ed., The Blakiston Company (1941).
These definitions indicate that the common and commercial meaning of the term “tachometer” includes an instrument used for measuring (or indicating) speed, velocity, or rate. Notably, the definitions leave room for “medical” tachometers that measure certain physiological parameters, such as a patient’s heart rate. Given these definitions, we can conclude that the common and commercial meaning of a “tachometer” includes certain medical instruments that measure heart rate.
The EN to heading 9018, HTSUS, provides as follows, in relevant part:
This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc.
The EN to heading 9029, HTSUS, provides as follows, in relevant part:
This heading includes: [. . .]
Apparatus indicating a speed of revolution or a linear speed in relation to a time factor (tachometers and speed indicators), other than those of heading 90.14 or 90.15. [. . .]
(B) SPEED INDICATORS AND TACHOMETERS
These instruments differ from the revolution counters and production counters of Part (A) above in that they indicate the number of revolutions, speed, output, etc., per unit of time (e.g., revolutions per minute, miles per hour, kilometres per hour, metres per minute). They are usually mounted on vehicles (cars, motorcycles, bicycles, locomotives, etc.) or machines (motors, turbines, paper?making machines, printing machinery, textile machinery, etc.). [. . .]
Speed indicators and tachometers of this heading may be fixed or portable, simple or multi?function (e.g., maximum or minimum), differential (in which case they give the difference between two speeds as a percentage), combined with an adding counter or a time meter or graphical recording device, etc. The heading also covers certain instruments which simultaneously record speed, mileage, time in motion and at a standstill, etc.
We first note that at least part of the subject pulse oximeters is classifiable under heading 9029, HTSUS, as a “tachometer.” As discussed in HQ 087550, the common and commercial meaning of the term “tachometer” includes certain instruments that measure a person’s heart rate. This finding comports with the explanation provided by the EN to heading 9029, HTSUS, which states that instruments classifiable under that heading “indicate the number of revolutions, speed, output, etc., per unit of time (e.g., revolutions per minute, miles per hour, kilometers per hour, metres per minute).” Here, the subject merchandise can provide pulse rate data with measurements between 30 bpm to 250 bpm. It indicates the number of heart beats per unit of time in minutes. Considering the definitions discussed in HQ 087550 and the subject merchandise’s functionality, we find that the heart rate measurement function of the subject pulse oximeters is properly described by heading 9029, HTSUS, and that the heading thus refers to part of the oximeters. However, because the entirety of the pulse oximeters is described under heading 9018, HTSUS, that heading ultimately applies.
The protestant’s submission amply demonstrates that, in its condition at importation, the subject merchandise has the general characteristics of a device used to aid medical professionals in diagnosing certain conditions through pulse oximetry, thereby constituting “instruments used in the medical sciences” under heading 9018, HTSUS. The subject pulse oximeters operate with an SpO2 accuracy of a root-mean square difference of less than or equal to 4.0% over the range of 70 to 100% of SaO2, and the accuracy of these results were confirmed by a controlled desaturation study. Should the pulse oximeters fail to register a signal, they will warn an operator of signal inadequacy. Indeed, the protestant’s submission shows that the pulse oximeters are of a caliber that a medical professional could rely on their measurements in conjunction with other data to diagnose levels of oxygenated blood. As such, the subject merchandise is properly classified, in the entirety and in its condition at importation, as “instruments used in the medical sciences.”
In reaching this determination, it is neither necessary nor appropriate for us to turn to the subject merchandise’s status under the FDA’s notification, identification, and registration regimes, as doing so would contravene the well-established principle “that statutes, regulations, and administrative interpretations not related to tariff purposes are not determinative of customs classification disputes.” Nothing the protestant put forward demonstrates that Congress contemplated the FDA regimes upon adopting the tariff term “instruments used in medical sciences.” An FDA determination that the subject merchandise constitutes a “medical device” speaks to that agency’s public health objectives and congressional mandate; it is not persuasive for this classification dispute.
We conclude that the subject pulse oximeters are classified under heading 9018, HTSUS, as “instruments used in medical sciences.”
HOLDING:
By application of GRI 1, the subject pulse oximeters are classified under heading 9018, HTSUS, specifically subheading 9018.19.95, HTSUS, which provides for, “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Other: Other.” The general column one rate of duty is free.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.19.95, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty.
The HTSUS is subject to periodic amendment, so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, including information on exclusions and their effective dates, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.
You are instructed to GRANT the Protest.
In accordance with Sections IV and VI of the CBP Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), you are to mail this decision, together with the CBP Form 19, to the Protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings, will make the decision available to CBP personnel, and to the public on the CBP website at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division