N351497

N351497 August 14, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 9026.20.4000; 8504.40.9540; 9018.90.7570; 9903.01.24; 9903.01.25; 9903.88.01; 9903.88.03; 9817.00.96 Juan Moreno Sandler, Travis and Rosenberg, PA 414 Jackson Street, Suite 200 San Francisco, CA 94111 RE: The tariff classification of Hemodialysis System Console components from China Dear Mr. Moreno: In your letter dated July 18, 2025, on behalf of your client, Outset Medical inc., you requested a tariff classification ruling. Descriptive literature was provided for our review. The three items under consideration are all described as parts designed for the Tablo Hemodialysis System Console, which is the core component of the Outset Medical Tablo System, a mobile, all-in-one hemodialysis machine designed for use in various care settings, including hospitals and homes. It integrates water purification and dialysate production, eliminating the need for separate equipment. The console features a touchscreen interface, wireless data communication, and automated functions to simplify dialysis treatment. The first item under consideration is described as a pressure sensor (part number PN-0006362), which is a spare component designed exclusively for the Tablo Hemodialysis System Console and is utilized for maintenance and repair of the system. This precision sensor monitors and transmits the fluid pressure upstream of the ultrafilter, a key operational parameter necessary for the safe and effective production of dialysate and overall dialysis treatment. The sensor’s functionality is wholly dependent on its integration within the Tablo Console’s custom-designed manifold, where it is securely housed to ensure accurate pressure measurement. In addition, it requires direct connection to the console’s proprietary electronics and embedded software, which processes and interprets the pressure data communicated via a serial interface. The sensor is neither interchangeable with, nor adaptable for use in, any other dialysis systems or general medical equipment. The pressure sensor is connected to the Tablo Console dialysate delivery breakout circuit board via an Outset specified 6-pin connector that mates with a matching connector on the circuit board. The signals from the pressure sensor are routed via ribbon cables to the Dialysis Sensor circuit board, which includes the circuitry and software to communicate with the sensor. The second item under consideration is described as the power supply module (PN-0006208), which is a medical-grade, replacement component designed exclusively for use in the Tablo Hemodialysis System Console. This module converts residential alternating current (AC) power from a standard wall outlet into a stable 24V, 1100W, direct current (DC) output, specifically calibrated to meet the power requirements of the Tablo Console’s electronic and electromechanical systems. The Power Supply Module is engineered with electrical specifications tailored for the operational demands of the Tablo Console and is not compatible with other medical devices or general-purpose equipment. To function, the module requires connection through three cable harnesses that link the power supply to both the AC input source and the console’s internal power architecture. Proprietary software monitors the power supply for faults and turns it on and off to perform self-tests of the power supply. The third item under consideration is described as the Base, degas chamber (PN-0004592), which is also a spare part designed exclusively for the Tablo Hemodialysis System Console, used specifically in the repair and maintenance of the system’s dialysate preparation process. Within the console, the degas chamber performs a critical function by removing entrained air from purified water prior to the formulation of dialysate, an essential step to ensure patient safety during hemodialysis treatment. The Base is a custom-engineered, injection-molded plastic manifold, purpose-built to support this degassing operation within the tightly controlled fluidic architecture of the Tablo Console. The Base is designed to interface exclusively with the mating degas chamber body. The Base, degas chamber’s dimensional specifications, material composition, and functional characteristics are unique to the system and have no general utility outside of the Tablo platform. The applicable subheading for the pressure sensor (part number PN-0006362) will be 9026.20.4000, 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 pressure: Electrical.” The general rate of duty will be free. The applicable subheading for the power supply module (PN-0006208) will be 8504.40.9540, HTSUS, which provides for “Electrical transformers, static converters…: Static converters: Other: Rectifiers and rectifying apparatus: Power Supplies: Other.” The general rate of duty will be free. The applicable subheading for the Base, degas chamber (PN-0004592) will be 9018.90.7570, 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: Other instruments and appliances and parts and accessories thereof: Other: Electro-medical instruments and appliances and parts and accessories thereof: Other: Other: Parts and accessories of dialysis instruments and apparatus.” 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 9026.20.4000, 8504.40.9540, and 9018.90.7570, 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, in addition to subheadings 9026.20.4000, 8504.40.9540, and 9018.90.7570, HTSUS, listed above. Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheadings 9026.20.4000 and 9018.90.7570, 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 9026.20.4000 and 9018.90.7570, HTSUS, listed above. Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 8504.40.9540, 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 8504.40.9540, 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, you may ref

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 jason.m.christie@cbp.dhs.gov. 
Sincerely,
 (for) James Forkan Acting Director National Commodity Specialist Division