The tariff classification of the Lumiflex Balloon Inflator from China

N355998 December 1, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9018.90.8000; 9903.01.24; 9903.01.25 Adam Gustafson STERIS 5960 Heisley Rd Mentor, OH 44060 RE: The tariff classification of the Lumiflex Balloon Inflator from China Dear Mr. Gustafson: In your letter dated November 13, 2025, you requested a tariff classification ruling. The Lumiflex Balloon Inflator (Part # BX00733223INT) is a single use, 60ml plastic device used to inflate and deflate a balloon of the LUMIFLEX 3-Stage Balloon Dilatation Catheter. This catheter is commonly used in gastrointestinal procedures to treat gastrointestinal strictures. During a procedure, the balloon inflator is used to either inflate the balloon, which is positioned in the patient’s gastrointestinal tract, by filling it with sterile water, sterile saline, or a contrast mixture via a catheter tube, or to deflate the balloon by extracting all fluid. The balloon inflator comprises mainly of a push rod, a cylinder barrel, a locking lever, a pressure gauge, and a connector tubing that connects to the balloon dilation catheter. In your letter, you propose classification under subheading 9018.39.0040, Harmonized Tariff Schedule of the United States (HTSUS), as a part of a catheter. We disagree. The courts have held that “the mere fact that two articles are designed to be used together is not alone sufficient to establish that either is a part of the other, or of their combined entity.” Westfield Manufacturing Company v. United States, 191 F. Supp. 578 (1961). In Schick X-Ray Co. v. United States, 271 F. Supp. 305 (1967), the court stated that, “[m]any ... objects, despite the fact that their usefulness is only in conjunction with other articles, retain a separateness of identity and a functional self-sufficiency which preclude their classification as parts.” In this instance, the balloon inflator is a distinct and separate commercial entity and not a part. Consistent with this interpretation, U.S. Customs and Border Protection classified a similar product, an "AG Cuffill" device, as a medical device under heading 9018, HTSUS, in Headquarters Ruling Letter (HQ) H339463, dated September 20, 2024. Therefore, the subject product will be classified elsewhere. The applicable subheading for the Lumiflex Balloon Inflator will be 9018.90.8000, HTSUS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: Other instruments and appliances and parts and accessories thereof: 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 10 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 9018.90.8000, 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 subheading 9018.90.8000, HTSUS, listed above. 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 Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division