CLA-2-84:OT:RR:NC:N1:105

Robert Leo
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Avenue, Ste. 2405
New York, NY 10022

RE: The tariff classification of canisters from Mexico, China, and Great Britain

Dear Mr. Leo:

In your letter dated October 20, 2025, on behalf of your client, Philips RS North America LLC, you requested a tariff classification ruling.

The items under consideration are described as Canisters (model numbers 1017774, 1135538, 1038825, 1135461, and 1093443B), which serve as parts of sieve bed filters. The sieve bed filters are components of portable oxygen concentrator (POC) medical devices such as the Millennium M10, EverFlo, SimplyGo and SimplyGo Mini. These POCs are for prescription use only by patients requiring supplemental oxygen. At the time of import, all Canisters are not yet filters, but rather components of the filters. They will later be filled with zeolite molecular beads that extract oxygen from room air, resulting in highly concentrated oxygen which is delivered to individuals whose oxygen levels are below a required healthy threshold.

The first two items are the M10 Sieve Canister Replacement (10LPM) under model number 1017774 and the M10 Canister, Sieve EFF, (10 LPM Mill) under model number 1135538. Both filters are produced in Mexico. The canister, once filled with zeolite pellets, selectively adsorbs nitrogen from the ambient air to produce a concentrated oxygen supply. A compressor inside the oxygen concentrator pulls in ambient air, which is composed of roughly 21% oxygen and 78% nitrogen. This air is then compressed and pushed into one of two identical sieve canisters. The molecular sieve material has a network of tiny, uniform pores. This material is highly effective at selectively adsorbing nitrogen molecules under high pressure. As the compressed air passes through the sieve, the nitrogen and other trace gases bind to the zeolite pellets, allowing the oxygen molecules to pass through freely. The newly purified, concentrated oxygen exits the canister and is collected in a reservoir tank. From there, it is delivered to the patient through a nasal cannula or mask at a prescribed flow rate, up to 10 liters per minute (LPM). While one sieve canister is adsorbing nitrogen, the other is in a regeneration cycle. The pressure in the saturated canister is released, causing the nitrogen to desorb (be released) from the zeolite and be vented back into the atmosphere. This regenerates the sieve material, preparing it for the next cycle. The third item is the RP-EverFlo Canister Assy .035x11.5 under model number 1038825 while the fourth item is the RP EverFlo Integrated Canister 0.035x12.5 under model number 1135461. Both filters are made in Mexico but the 1135461 can also be made in China. These filters work similarly to the two filters discussed above but have a different shape and size that is designed to fit the EverFlo oxygen concentrators.

Finally, the fifth item is the RP SimplyGo Sieve Canister under model number 1093443B. This filter is produced in Great Britain and also operates similarly to the aforementioned canisters. The filter is designed for the SimplyGo models and operates through Pressure Swing Adsorption (PSA) to separate nitrogen from the air, delivering highly concentrated oxygen. The SimplyGo concentrator uses a pair of these canisters, which work in tandem to ensure a continuous supply of oxygen.

We find the Canisters to be integral internal component parts of Philips POC’s, medical devices which provide continuous or pulse flow of 90%-95% oxygen to users with chronic respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, Asthma, and Emphysema. They provide supplemental oxygen in order to maintain their healthy blood oxygen levels. The Canisters are each uniquely designed to work exclusively with Philips POC’s, which are solely for alleviation/therapy of a chronic condition and used to enable airway clearance. The device does not play a role in diagnosis, prevention, monitoring, treatment, compensation for injury, support of anatomy, support of physiological process, or control of conception.

In your letter, you propose classification under subheading 9019.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides, in relevant part, for parts of an oxygen therapy apparatus. We disagree with the suggested classification. The imported Canisters are parts of sieve bed filters used inside the oxygen concentrator. Headquarters Ruling H024411, dated July 22, 2009, states, “a subpart of a particular part of an article is more specifically provided for as a part of that part than as a part of the whole.” Therefore, they are more specifically classified as a part of the filters rather than as a part of the oxygen concentrators.

Accordingly, the applicable subheading for the Canisters (model numbers 1017774, 1135538, 1038825, 1135461, and 1093443B) will be 8421.99.0180, HTSUS, which provides for “Centrifuges, including centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; parts thereof: Parts: Other: Other.” The general rate of duty will be free.

Products of Mexico as provided by heading 9903.01.01 in Section XXII, Chapter 99, Subchapter III, U.S. Note 2(a), HTSUS, other than products classifiable under headings 9903.01.02, 9903.01.03, 9903.01.04, and 9903.01.05, HTSUS, will be subject to an additional 25 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.01, in addition to subheading 8421.99.0180, HTSUS, listed above. Articles that are entered free of duty under the terms of general note 11 to the HTSUS (U.S.-Mexico-Canada Agreement (USMCA)), including any treatment set forth in subchapter XXIII of Chapter 98 and subchapter XXII of chapter 99 of the HTSUS, will not be subject to the additional ad valorem duties provided for in heading 9903.01.01. If your product is entered duty free as originating under the USMCA, you must report heading 9903.01.04, HTSUS, in addition to subheading 8421.99.0180, HTSUS.

Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings 9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition to subheading 8421.99.0180, HTSUS, listed above.

Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of China, Hong Kong, and Macau will be subject to an additional ad valorem rate of duty of 10 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25 or exclusion subheading, in addition to subheading 8421.99.0180, HTSUS, listed above.

Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of Mexico are not subject to reciprocal tariffs. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e., 9903.01.27, in addition to subheading 8421.99.0180, HTSUS, listed above.

Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of the European Union with an ad valorem (or ad valorem equivalent) rate of duty under column 1-General less than 15 percent will be subject to an additional ad valorem rate of duty of 15 percent minus the column 1-General duty rate. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.02.20, in addition to subheading 8421.99.0180, HTSUS, listed above.

Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 8421.99.0180, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading 9903.88.01 in addition to subheading 8421.99.0180, HTSUS, listed above.

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.

However, the additional duties imposed by heading 9903.01.01, 9903.01.20, 9903.01.24, 9903.01.25 or 9903.88.01, shall not apply to goods for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50, and 9802.00.60.

Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.

In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the United States Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped.” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by CBP:

(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped.

In Headquarters Ruling Letter (HQ) H301481, dated June 14, 2019, CBP concluded that the specific class of persons for which Inogen’s portable oxygen concentrator was intended was physically handicapped and determined that the portable oxygen concentrator qualified for duty-free treatment under subheading 9817.00.96, HTSUS. The oxygen concentrators that the Canisters are used with operate in a similar manner. Therefore, it is the opinion of this office that the Canisters (model numbers 1017774, 1135538, 1038825, 1135461, and 1093443B) are also eligible for duty-free treatment under subheading 9817.00.96, HTSUS.

The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/.

The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.

This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Jason Christie at [email protected].
Sincerely,

(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division