CLA-2-84:OT:RR:NC:N1:102
9903.88.01; 9903.88.03; 9817.00.96
Juan Moreno
Sandler, Travis & Rosenberg, P.A.
414 Jackson Street, Suite 200
San Francisco, CA 94111
RE: The tariff classification of pumps from Germany and a valve and sensor from China
Dear Mr. Moreno:
In your letter dated May 9, 2025, you requested a tariff classification ruling on behalf of Outset Medical Inc.
The five products at issue are installed in the Tablo Hemodialysis System Console, which provides
hemodialysis treatment for individuals with End-Stage Renal Disease (ESRD). The console, which features
four wheels, is comprised of a housing equipped with various components that together remove toxins, waste
and fluid from the body.
The Ultrafilter Pump, part number PN-0005384-F, is a component of the console’s water purification
subsystem, which produces dialysis-grade water from tap water. The gear pump transports water from the
reverse osmosis filtration system to a downstream ultrafilter. The pump features tubing connections that
interface with the console, and the pump’s electrical connectors and signal pin configurations are specifically
compatible with the console’s electronics and software.
The Dialysate Piston Pump, part number PN-0007291-F, regulates the flow of dialysate fluid to the dialyzer
filter, which is used to extract toxins from the blood. The stroke volume of the pump is calibrated to achieve
the range of flow rates necessary for dialysis treatments. The motorized pump features tubing connections
that interface with the console, and the pump’s electrical connectors and signal pin configurations are
specifically compatible with the console’s electronics and software.
The Bicarbonate Piston Pump, part number PN-0007294-F, meters the flow of bicarbonate solution used in
the production of dialysate, which is used to remove toxins from the user’s bloodstream. The stroke volume
of the pump is calibrated to deliver the flow rates required for dialysis. The motorized pump features tubing
connections that interface with the console, and the pump’s electrical connectors and signal pin
configurations are specifically compatible with the console’s electronics and software.
The level detector sensor, part number PN-003091-F, is an electronic sensor designed to detect the presence
of air or water within the air separation chamber of the console. The console is used to remove dissolved air
from the purified water prior to the production of dialysate solution. The sensor is designed to interface
mechanically with the air removal chamber and detect when air has accumulated in the chamber and needs to
be pumped out of the chamber. The sensor’s electrical connectors and signal pin configurations are
specifically designed for compatibility with the console’s electronics and software. The sensor is sourced
from China.
The Carbon Flush Valve, part number PN-0004691-F, is a three-way solenoid valve. Once actuated, the valve
removes excess carbon from the carbon filters located in the console’s water purification subsystem. The
copper valve is designed to be installed onto a custom designed manifold, and the electrical connectors and
signal pin configurations are specifically compatible with the console’s electronics and software. The valve is
sourced from China.
The applicable subheading for the Ultrafilter Pump, part number PN-0005384-F, will be 8413.60.0090,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for Pumps for liquids, whether or
not fitted with a measuring device; liquid elevators; part thereof: Other rotary positive displacement pumps:
Other: Other. The general rate of duty will be Free.
The applicable subheading for the piston pumps, part numbers PN-0007291-F and PN-0007294-F, will be
8413.50.0090, HTSUS, which provides for Pumps for liquids, whether or not fitted with a measuring device;
liquid elevators; part thereof: Other reciprocating positive displacement pumps: Other: Other. The general
rate of duty will be Free.
The applicable subheading for the level detector sensor, part number PN-0003091-F, will be 9026.10.2080,
HTSUS, which provides for Instruments and apparatus for measuring or checking the flow, level, pressure or
other variables of liquids or gases (for example, flow meters, level gauges, manometers, heat meters),
excluding instruments and apparatus of heading 9014, 9015, 9028 or 9032; parts and accessories thereof: For
measuring or checking the flow or level of liquids: Electrical: Other. The general rate of duty will be Free.
The applicable subheading for the Carbon Flush Valve, part number PN-0004691-F, will be 8481.80.9005,
HTSUS, which provides for Taps, cocks, valves and similar appliances, for pipes, boiler shells, tanks, vats or
the like, including pressure-reducing valves and thermostatically controlled valves; parts thereof: Other
appliances: Other: Solenoid valves. The general rate of duty will be 2 percent ad valorem.
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 9026.10.2080 or 8481.80.9005, 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 from all countries
will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the
Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading
8413.60.0090, 8413.50.0090, 9026.10.2080, or 8481.80.9005, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 9026.10.2080, 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, i.e., 9903.88.01,
in addition to subheading 9026.10.2080, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 8481.80.9005, 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, i.e., 9903.88.03,
in addition to subheading 8481.80.9005, HTSUS, listed above.
In your submission, you requested consideration of a secondary classification for the articles above under
9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the
use or benefit of the permanently or chronically physically or mentally handicapped. Chapter 98, Subchapter
XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as
including “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 oneself, performing manual tasks,
walking, seeing, hearing, speaking, breathing, learning, or working.”
The primary issue is whether the articles are specially designed or adapted for the use or benefit of the
handicapped within the meaning of Nairobi Protocol. Although the legislative history of the Nairobi Protocol
discusses the concerns of Congress that the design, modification, or adaptation of an article must be
significant so as to clearly render the article for use by handicapped individuals, no specific definition of
these terms was established by Congress. Since it is difficult to establish a clear definition of what is
specially designed or adapted, various factors must be utilized on a case-by-case basis to determine whether a
given article is specially designed or adapted within the meaning of this statute.
In Treasury Directive 92-77, dated August 3, 1992 (Volume 26 Customs Bulletin Issue 35, dated August 26,
1992), U.S. Customs and Border Protection (CBP) set forth its position regarding certain issues arising under
the Nairobi Protocol. The first issue concerned the interpretation of the term specially designed or
adapted. CBP pointed out that a primary factor to be considered in determining whether an article was
specially designed and adapted was whether the article was easily distinguishable, by properties of the design
and the corresponding use specific to this unique design, from articles useful to non-handicapped individuals.
Therefore, if an article is solely dedicated for use by the handicapped it is CBP’s position that this would be
conclusive evidence that the article is specially designed or adapted for the handicapped for purposes of the
Nairobi Protocol.
In Headquarters Ruling Letter 556449, dated May 5, 1992, CBP set forth five factors it would consider in
determining whether an article is specially designed or adapted for the use or benefit of handicapped persons.
These factors include: (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.
The Tablo console is used by individuals to self-manage ESRD, which requires the removal of toxins, waste,
and fluid from the body. CBP previously reviewed the Tablo Hemodialysis Console in New York Ruling
Letter N345258, dated February 7, 2025, and explained that by design, function, and use, the console is an
article “specially designed or adapted” for the handicapped for the purposes of subheading 9817.00.96,
HTSUS.
The issue under consideration is whether the aforementioned articles are specially designed and adapted for
use in the Tablo console. Based on the information provided, the subject articles feature electrical
connections, and in some instances, tubing that solely works with the console. Accordingly, we believe the
subject articles are exclusively used with the Tablo Hemodialysis Console and therefore, eligible for
secondary classification in subheading 9817.00.96, HTSUS, which provides for Articles 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: Other, free of duty and the Merchandise Processing Fee (MPF).
Please note, the additional duties imposed by subheadings 9903.01.24, 9903.0125, 9903.88.01 and
9903.88.03 do not apply to goods for which entry is properly claimed under a provision of chapter 98 of the
HTSUS, except for goods entered under subheading 9802.00.40, 9802.00.50, 9802.00.60 or 9802.00.80.
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 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 Sandra Martinez at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division