CBP Finds Pulse Oximeters Classifiable as Medical Instruments, not Tachometers

CBP will grant Lorte Technologies, Inc.'s protest on the tariff classification of its pulse oximeters from China, according to a June 18 decision posted by CBP on Aug. 19. The agency ruled that, even though part of the pulse oximeters could fall under the classification for tachometers, considering the whole instrument would place the oximeters under a different classification category for medical instruments.

"This matter turns on the application of GRI 1, specifically whether the subject merchandise meets the terms of heading 9018, HTSUS, as 'instruments used in medical sciences' or the terms of heading 9029, HTSUS, as a 'tachometer,'" CBP said. "It is a well-established principle 'that statutes, regulations, and administrative interpretations not related to tariff purposes are not determinative of customs classification disputes.' It is also well-established that 'in order to produce uniformity in the imposition of duties, the dutiable classification of articles imported must be ascertained by an examination of the imported article itself, in the condition in which it is imported.'"

Therefore, "if the subject pulse oximeters are described in whole by the terms of one of the headings, then that heading applies, and the succeeding GRIs are inoperative," CBP said.

CBP had liquidated the oximeters when they were entered between Jan. 14, 2022, and June 22, 2022, under subheading 9029.20.40, which provides for “Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9018; stroboscopes; parts and accessories thereof: Speedometers and tachometers; stroboscopes: Other speedometers and tachometers.”

The agency described the oximeters as “designed to readily examine the oxygen saturation of arterial hemoglobin and the pulse rate of patients at home and in clinical environments. The information provided by the pulse oximeters, alone, cannot form the basis for a diagnosis; rather, it must be read together with other clinical information to determine if the blood is well oxygenated.”

But Lorte Technologies had entered the oximeters under subheading 9018.19.95, 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: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Other: Other.”

When protesting CBP's classification, Lorte Technologies said that the pulse oximeters had documentation from the FDA showing that these types of oximeters serve as medical devices. The company also said it had registered and notified the FDA of Lorte’s intent to market the oximeters as medical devices.

In reviewing Lorte Technologies’ claims, CBP explored the definition of tachometers, which was the agency’s initial designation for the oximeters. Tachometers measure or indicate speed, velocity or rate, and there are also “medical” tachometers that measure certain physiological parameters, such as a patient’s heart rate, CBP said. “Given these definitions, we can conclude that the common and commercial meaning of a ‘tachometer’ includes certain medical instruments that measure heart rate.”

Furthermore, the ability of the oximeters to measure heart rate fits under the subheading for tachometers, according to CBP.

But while CBP found that "the heart rate measurement function of the subject pulse oximeters is properly described by heading 9029, and that the heading thus refers to part of the oximeters," it said that because the entirety of the pulse oximeters is described under heading 9018, "that heading ultimately applies."

"The protestant’s submission amply demonstrates that, in its condition at importation, the subject merchandise has the general characteristics of a device used to aid medical professionals in diagnosing certain conditions through pulse oximetry, thereby constituting ‘instruments used in the medical sciences’ under heading 9018, HTSUS.” The oximeters also are of a caliber used by medical professionals when diagnosing patients.

Because of these reasons, the oximeters should be classified as being under the medical sciences heading, CBP said. However, the agency also said that the FDA’s determination of a medical device “is not persuasive for this classification dispute” as the determination “speaks to that agency’s public health objectives and congressional mandate.”