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 a filter, a valve kit, pump assemblies and a pump cover from China
Dear Mr. Moreno:
In your letter dated July 2, 2025, you requested a tariff classification ruling, on behalf of your client, 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 is comprised of a
housing equipped with four wheels and various components that together remove toxins, waste and fluid
from the body. The products are intended to be shipped as replacement parts used to maintain and repair of
the console.
The Ultrafilter, part number PN-0002624, is a filter that consists of a plastic housing that encases hollow
plastic micro-tubes. The walls of the hollow fibers are membranes that remove contaminants from the liquid
passing through the filter. The filter is designed to remove bacteria and endotoxins from water used in
dialysate production, as well as from the dialysate prior to delivery. The filter is imported in a box that
contains 10 filters.
The Concentrate Routing Valve Kit, part number PN-0008964-F, consists of a valve and components that
mount and contribute to the function of the valve, e.g., a mounting bracket, tubing, screws and washers. Once
actuated by a separately imported solenoid, the housed valve diverts concentrated saline solution rejected by
the system’s reverse osmosis filters during dialysis treatment. The valve also recirculates chemical
disinfectant during disinfection cycles. The steel valve connects to the solenoid and the console via
customized connectors, tubing and a wire harness.
The Flush Gland Pump Assembly, part number PN-0003377-F, which delivers dialysate to the user, consists
of a gear pump and a motor. The 24-volt motor of the assembly features a tachometer output, and custom
designed pin connectors, allowing it to be electrically compatible with the Tablo console. The steel pump
also features fluid connections that consist of two plastic tubes.
The Vane Pump and Motor Assembly, part number PN-0003356-F, which delivers water to the reverse
osmosis filtration unit within the console, consists of a pump and a motor. The steel pump features custom
designed fluid connections, and the motor features electrical connections designed to plug into a connector on
the console’s circuit board.
The Blood Pump Cover, part number PN-DWG-1779, is used in a rotary peristaltic pump, which circulates
blood through the dialyzer and to the patient. The cover, which is uniquely configured, features arrows that
indicate the rotation of the pump and insertions that allow for tubing to be appropriately organized within the
pump. The cover also serves as a protective housing for the rotor, a component of the pump head.
The applicable subheading for the individual filters will be 8421.21.0000, Harmonized Tariff Schedule of the
United States (HTSUS), which provides for Centrifuges, including centrifugal dryers; filtering or purifying
machinery and apparatus, for liquids or gases; parts thereof: Filtering or purifying machinery and apparatus
for liquids: For filtering or purifying water. The general rate of duty is Free.
The applicable subheading for the valve kit 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 is 2 percent ad valorem.
The applicable subheading for both pump assemblies will be 8413.60.0090, 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 pump cover will be 8413.91.9096, HTSUS, which provides for Pumps for
liquids, whether or not fitted with a measuring device; liquid elevators; part thereof: Parts: Of pumps: Other:
Other. The general rate of duty will be Free.
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 subheadings 8421.21.0000, 8481.80.9005, 8413.60.0090, and 8413.91.9096, 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
8421.21.0000, 8481.80.9005, 8413.60.0090, and 8413.91.9096, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheadings 8421.21.0000, 8413.60.0090, and 8413.91.9096, 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 subheadings 8421.21.0000, 8413.60.0090, and
8413.91.9096, 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.
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 Tablo
console is used to self-manage ESRD, which requires the removal of toxins, waste, and fluid from the body.
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 are uniquely designed, and
feature electrical connections, and in some instances, fluid connections that solely work with the console.
Accordingly, we believe the subject articles are exclusively used with the Tablo Hemodialysis System
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 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 Sandra Martinez at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division