The tariff classification of Precision Flow Rate Tubing, High-Flo Subcutaneous Safety Needle Sets, and Adapter from Nicaragua

N360225 April 30, 2026 CLA-2-90:OT:RR:NC:N3:143 CATEGORY: Classification TARIFF NO.: 9018.39.0050; 9018.90.8000 Natan Tubman Buchanan Ingersoll & Rooney PC 1600 K Street Washington, DC 20036 RE: The tariff classification of Precision Flow Rate Tubing, High-Flo Subcutaneous Safety Needle Sets, and Adapter from Nicaragua Dear Mr. Tubman: In your letter dated March 31, 2026, you requested a tariff classification ruling on behalf of your client, Koru Medical Systems, Inc. The items in consideration are the Precision Flow Rate Tubing, High-Flo Subcutaneous Safety Needle Sets, and Adapter. The Precision Flow Rate Tubing is made of medical grade non-DEHP PVC tubing and features luer connectors and disposable plastic end caps on both ends, as well as a slide clamp. It is designed to connect to a syringe on one end and, on the other end, to a High-Flo Needle Set or vascular access device. The plastic end caps help prevent contamination, and each Precision Flow Rate Tubing is individually packaged in a sterile pouch. Precision Flow Rate Tubing is specifically designed to work exclusively with Freedom60 and FreedomEdge Infusion Systems. The High-Flo Subcutaneous Safety Needle Sets are single-use infusion sets consisting of a 90-degree stainless steel grade needle mounted to a butterfly assembly on one end, a PVC tubing, a slide clamp, and leur connectors on either end. High-Flo Subcutaneous Safety Needle Sets are intended for the subcutaneous infusion of liquid medicines from an external infusion pump or syringe. The sets are packaged individually in terminally sterilized single barrier systems and available in multiple configurations with variations in needle gauge, wall thickness, number of needle legs, and needle lengths. High-Flo Subcutaneous Safety Needle Sets are specifically designed to work with Freedom60 and FreedomEdge Infusion Systems. The Adapter is a plastic molded article that is reusable and removable. It is intended to hold and position the syringe flange within the pump. The Adapter is specifically designed for the Freedom 60 Infusion System. However, as you noted the Freedom60 Infusion System can also operate independently without the Adapter. The Freedom60 and FreedomEdge Infusion Systems are mechanically operated devices that require no batteries or electrical power. Using a constant-force spring mechanism, they deliver medication at a steady, controlled rate by applying consistent pressure to the syringe plunger. Their portable design enables use in home, clinical and other settings by patients (adults, adolescents and pediatrics), caregivers, or healthcare providers. Based on your first submission, both infusion systems are specifically intended for patients with immunodeficiencies and certain neurological conditions and are indicated for Subcutaneous Immunoglobulin (SCIg) administration, Empaveli infusion for those suffering from Paroxysmal Nocturnal Hemoglobinuria (PNH) and intravenous (IV) antibiotic infusions. They provide increased flexibility, allowing extended or lifelong treatment regimens to be managed outside of hospitals. This offers an alternative to intravenous (IV) immunoglobulin therapy, enabling subcutaneous administration in home environments. Your second submission states that the infusion systems are specifically designed to work with a limited set of medications, namely SCIg replacement therapies for individuals with Primary Immunodeficiency Disorders (PID). PIDs are caused by the absence or malfunction of components of the immune system, resulting in significantly reduced physical health, abilities, psychosocial wellbeing and overall quality of life compared to the general population. You also note that the flexibility to administer SCIg replacement therapy in various settings reduces the need for frequent hospital visits, enhances autonomy, and improves quality of life, thereby helping to manage symptoms of PID. In your submission, you propose classification of the Precision Flow Rate Tubing as a product that is “like” syringes, needles, catheters, and cannulae under subheading 9018.39.0040, Harmonized Tariff Schedule of the United States (HTSUS). We disagree. Syringes, needles, catheters and cannulae are intended for delivering or removing fluids from the body, administering medications, or accessing blood vessels and other body cavities. The Precision Flow Rate Tubing is designed to connect to a syringe and the High-Flo Needle Set or vascular access device. It is dissimilar to syringes, needles, catheters, and cannulae. Therefore, it will be classified elsewhere. The applicable subheading for the Precision Flow Rate Tubing 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. You also suggested classification for the High-Flo Subcutaneous Safety Needle Sets under subheading 9018.32.0000, HTSUS. We disagree. The High-Flo Subcutaneous Safety Needle Sets are more than just needles and are similar to “needles, catheters, cannulae, and the like…” and properly classified within subheading 9018.39.00. The applicable subheading for the High-Flo Subcutaneous Safety Needle Sets will be 9018.39.0050, 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: syringes, needles, catheters, cannulae and the like; parts and accessories thereof: other: other.” The general rate of duty will be free Lastly, you suggested classification for the Adapter under subheading 9018.39.0040, HTSUS. We disagree. Based on your description, the adapter is an accessory for the Freedom60, not a syringe or a similar product. It will be classified elsewhere. The applicable subheading for the Adapter 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. In your submission you also requested consideration of a secondary classification under 9817.00.96, HTSUS, which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “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.” The term “blind or other physically or mentally handicapped persons” includes “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 one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.60, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the United States Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by CBP: (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. The Freedom60 and FreedomEdge Infusion Systems are designed for patients with immunodeficiencies and certain neurological conditions, primarily for administering SCIg therapies and specific medications. While these devices help manage PIDs and related conditions, there is no evidence that they directly and permanently limit a person’s ability to perform major life activities or are associated with a specific physical handicap. Although these systems are sometimes used to address lung infections, skin infections, or dermatitis in PID patients, these conditions are not always permanent and can often be managed or cured. Improving a patient’s confidence or quality of life does not mean they are substantially limited in major life activities. Therefore, in our opinion, the Freedom60 and FreedomEdge Infusion Systems do not meet the requirements for duty-free treatment under subheading 9817.00.96. Consequently, the Precision Flow Rate Tubing, High-Flo Subcutaneous Safety Needle Sets, and Adapter, specifically designed to work exclusively with for Freedom60 and FreedomEdge Infusion Systems, are also ineligible for duty-free treatment under subheading 9817.00.96. The 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/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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 Dionisia Melman at dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division