The country of origin of pulse oximetry sensors

N359536 March 25, 2026 OT:RR:NC:N1:105 CATEGORY: Origin Alexander Chinoy Covington & Burling LLP One CityCenter, 850 Tenth Street NW Washington, DC 20001 RE: The country of origin of pulse oximetry sensors Dear Mr. Chinoy: In your letter dated March 6, 2026, on behalf of your client, Masimo Corporation, you requested a country of origin ruling on pulse oximetry sensors. Descriptive literature was provided for our review. The items under consideration are described as Low Noise Cabled Sensors (LNCS), which are oxygen saturation sensors used in medical settings to monitor a patient’s oxygen levels. The first sensor is a wrap-around style sensor (SKU number 1862) and the second is a fold-over style sensor (SKU number 2329). While both sensors attach to patients in distinct ways, both styles rely on the same sensor components. The wrap-around sensors are placed on a patient by wrapping it around a finger, toe, thumb, hand, or foot. They are attached with a connector and cable. Wrap-around sensors are available in adult, pediatric, infant, and neonatal sizes. The fold-over sensors are placed over a patient’s finger or toe and are then attached with a connector and cable. The design research, product development, and materials selection for both types of sensors take place in the United States and are functionally composed of a component array, with two primary functional components. The first is an emitter component made up of two light-emitting diodes (LED) electrically connected into one subassembly. The emitter is made of a U.S.-origin leadframe, LED chips, and epoxy, and Japanese-origin bonding wire and transfer mold compound. The second is a photodetector component featuring a photodiode electrically connected to a base to form a photodetector subassembly. The detectors are made of U.S.- origin epoxy, a Malaysian-origin leadframe, a Taiwanese or Malaysian origin photodiode chip, and Japanese-origin transfer mold compound and bonding wire. The emitter component and detector component are further electrically connected to form a sensor array. That sensor array is then further attached to other materials, including a Chinese-origin cable and connector assembly, and a U.S.-origin adhesive film tape enclosure. Then, either a second film-based adhesive applicator tape, a woven fabric with adhesive applicator tape, or a Velcro-based fabric applicator tape is applied. In operation, the emitter array is positioned on one side of the application site, while the detector array is positioned on the opposite side. One LED in the emitter component emits infrared light, and the other emits red light. The detector component then measures the amounts of infrared and red light that pass through the patient. Given that oxygenated blood absorbs more infrared light, and deoxygenated blood absorbs more red light, the detector measurements can be used to calculate the patient’s blood oxygen percentage. The emitter half of the sensor array is assembled in the United States from U.S.-origin LEDs. This U.S. emitter component manufacturing involves taking a pair of U.S.-origin LEDs, and electrically connecting them, resulting in a discrete specialized emitter component specifically designed for further assembly into the completed sensor array. The detector component half of the sensor is also assembled in the United States. It is made with a generic photodiode from Taiwan or Malaysia. These photodiodes are imported into the United States as a diced wafer of individual photodiodes (i.e., the wafer is adhered to a backing and the individual photodiodes are singulated, so that it still resembles a wafer, but each individual photodiode is separated from adjacent photodiodes prior to importation attached to the wafer-shaped backing). Once the emitter and detector components are created in the United States, they are then sent to Malaysia where they are electrically connected. For this step, both sensor styles proceed with identical soldering of the emitter and detector to wires, soldering of the detector shield to the wire, and final packaging. For the wrap-around style sensor, the wires are routed between the top and bottom head tapes, and the tapes are secured using a tape wrap before applying both the face tape and the printed release liner to the sensor. For the fold-over style sensor, the wires are routed on the bottom tape, and the top and bottom tapes are folded and bonded together without a separate tape wrap. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In this case, the Low Noise Cabled Sensors (both the wrap around and the fold over styles) are assembled in Malaysia using a U.S.-origin emitter component (capable of emitting light if it is electrically connected to an energy source), a U.S.-origin detector component (capable of receiving light and converting it into an electrical signal), and a Chinese origin cable and connector assembly. In our opinion, the addition of the cable and connector assembly, tape, and final packing in Malaysia do not constitute a complex and meaningful operation, and therefore, do not result in a substantial transformation. We find that the emitter component and detector component manufactured in the United States, which constitutes the essence of the sensor’s functionality, are not substantially transformed by the processing performed in Malaysia. Their name, character, and use remain unchanged. Therefore, the country of origin of the Low Noise Cabled Sensors (both the wrap around and the fold over styles) will be the United States. 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 jason.m.christie@cbp.dhs.gov. Sincerely, (for) James Forkan Designated Official Performing the Duties of the Division Director National Commodity Specialist Division