← Product Code [FMI](/productcode/FMI) · K260933 # Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) (K260933) _Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · FMI · Aug 7, 2026 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K260933 ## Device Facts - **Applicant:** Hangzhou Qiantang Longyue Biotechnology Co., Ltd. - **Product Code:** [FMI](/productcode/FMI.md) - **Decision Date:** Aug 7, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic, Pediatric ## Indications for Use This product is intended for use in the withdrawal and injection of fluids for medical purposes. This product is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. ## Device Story Single-use sterile hypodermic needle; used for intradermal, subcutaneous, or intramuscular fluid injection/withdrawal. Device components: needle tube, hub, safety cover, hinge, protective sheath. Operation: user attaches needle to standard luer slip/lock syringe; manually pivots safety cover away for use; after procedure, manually pivots cover over needle until locked to shield tip. Used by healthcare professionals in clinical settings. Benefits: facilitates fluid delivery while providing integrated sharps injury prevention mechanism. ## Clinical Evidence No clinical data. Bench testing only. Evaluated physical/mechanical properties (ISO 7864, ISO 9626, ISO 6009, EN ISO 8536-4), safety mechanism performance (per FDA guidance), Luer connector compatibility (ISO 80369-7), sterility (EN ISO 11137-2), and biocompatibility (ISO 10993 series including cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility). ## Technological Characteristics Materials: medical-grade polypropylene (PP) and SU5304 stainless steel. 6% Luer female conical connector (ISO 80369-7). Sizes: 18G-25G, 16mm-51mm lengths, Regular/Thin Wall. Sterilization: electron beam irradiation (SAL 10^-6). Manual safety mechanism; no electronic or software components. ## Regulatory Identification A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. ## Predicate Devices - Terumo SurGuard 3 Safety Hypodermic Needle ([K152362](/device/K152362.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **U.S. FOOD & DRUG** ADMINISTRATION August 7, 2026 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. % Ren Jiangfeng Regulatory Affairs Manager Shanghai Lingfu Technology Co., Ltd. Rm. 1115, Block A, Xuhui Vanke Centre, # 55 Ding'An Rd., Xuhui District Shanghai, Shanghai 200235, China Re: K260933 Trade/Device Name: Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 8, 2026 Received: July 8, 2026 Dear Ren Jiangfeng: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260933 - Ren Jiangfeng Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K260933 - Ren Jiangfeng Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # SHRUTI N. MISTRY -S Shruti Mistry Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K260933 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | | | | | Please provide your Indications for Use below. | | | ? | | This product is intended for use in the withdrawal and injection of fluids for medical purposes. This product is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. | | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? | | Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? | {4} 510(k) #: K260933 # 510(k) Summary Prepared on: 2026-08-07 Contact Details 21 CFR 807.92(a)(1) Applicant Name Hangzhou Qiantang Longyue Biotechnology Co., LTD Applicant Address Room 104, 201, 301, 302, Building 12, Block 1, No. 619 Wangmei Road, Linping Subdistrict, Linping District Hangzhou Zhejiang 310000 China Applicant Contact Telephone 86-17775381549 Applicant Contact CHEN Meijun Applicant Contact Email meijun_chen@nextech-x.com Correspondent Name Shanghai Ling Fu Technology Co., Ltd. Correspondent Address Room 1115, Block A, Xuhui Vanke Centre, No. 55 Ding'an Road, Xuhui District Shanghai Shanghai 200235 China Correspondent Contact Telephone 86-21-33561520 Correspondent Contact Ren Jiangfeng Correspondent Contact Email jiangfeng.ren@llins-tech.com Device Name 21 CFR 807.92(a)(2) Device Trade Name Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) Common Name Hypodermic single lumen needle Classification Name Needle, Hypodermic, Single Lumen Regulation Number 880.5570 Product Code(s) FMI Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K152362 Terumo SurGuard 3 Safety Hypodermic Needle FMI Device Description Summary 21 CFR 807.92(a)(4) The Safety Sterile Hypodermic Needles are single-use medical devices intended for the injection of medicinal liquids into human intradermal, subcutaneous, or intramuscular tissues. The device primarily consists of a safety cover, needle hub, needle tube, protective {5} sheath, and hinge. The needle hub is equipped with a 6% Luer female conical connector that conforms to ISO 80369-7. This connector allows the device to be securely connected to a syringe equipped with a compatible 6% Luer male conical connector. The device is manufactured primarily from medical-grade polypropylene (PP) and SU5304 stainless steel. To reduce the risk of accidental needlestick injury after use, the device incorporates a manually activated needle safety feature. Prior to removing the protective sheath, the user must manually pivot the safety cover away from the needle to allow access for use. After completion of the injection, the user must again manually pivot the safety cover over the exposed needle until it engages and locks in place, thereby fully shielding the needle. The safety mechanism is not automatically or passively activated and requires deliberate user action to engage. The Safety Sterile Hypodermic Needles are supplied sterile and are sterilized using electron beam irradiation. The devices have a shelf life of five years. They are available in various sizes to accommodate different clinical needs, including needle gauges ranging from 18G to 25G and nominal needle lengths ranging from 16 mm to 51 mm, in both Regular Wall (RW) and Thin Wall (TW) configurations. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) This product is intended for use in the withdrawal and injection of fluids for medical purposes. This product is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The Indications for Use for the subject device, Safety Sterile Hypodermic Needles, and the predicate device, Terumo SurGuard 3 Safety Hypodermic Needle (K152362), are not identical in exact wording, but they share the exact same fundamental intended use. Both devices are intended to interface with standard Luer syringes for the fluid delivery into the body, and both incorporate a manually activated safety shield to minimize the risk of accidental needlestick injuries after the procedure is complete. ## Technological Comparison 21 CFR 807.92(a)(6) The subject device, the Safety Sterile Hypodermic Needles, has the same basic technological characteristics, design, materials, and principle of operation as the legally marketed predicate device, the Terumo SurGuard 3 Safety Hypodermic Needle (K152362). The minor dimensional differences between the subject and predicate devices merely provide healthcare professionals with a broader range of options to accommodate varying clinical needs (e.g., deeper tissue injections or varying fluid viscosities). These size variations do not alter the fundamental scientific technology, principle of operation, or intended therapeutic effect of the device. Comprehensive bench testing has demonstrated that the subject device's various dimensions perform safely and effectively. Therefore, the technological characteristics of the subject device are substantially equivalent to the predicate device and do not raise any different questions regarding safety and effectiveness. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The subject device underwent a comprehensive suite of nonclinical tests to verify its safety and effectiveness for its intended use. The performance evaluation encompassed the following broad categories: 1) Physical, Mechanical, and Chemical Performance Testing evaluated needle appearance, dimensions, stiffness, resistance to breakage, corrosion resistance, bond strength between the hub and needle tube, lumen patency, particulate contamination, color coding, and applicable chemical properties. The testing referenced EN ISO 7864:2016, ISO 9626:2016, ISO 6009:2016, and EN ISO 8536-4:2020. 2) Needlestick Prevention Mechanism The safety mechanism was evaluated for activation force, resistance to premature activation, strength after activation, drop impact resistance, puncture resistance, and simulated clinical use. The simulated clinical evaluation referenced FDA's Medical Devices with Sharps Injury Prevention Features — Guidance for Industry and FDA Staff. 3) Luer Connector Compatibility The 6% Luer female connector was evaluated for liquid leakage, air leakage, stress cracking, axial separation, torque resistance, and resistance to thread overriding in accordance with ISO 80369-7:2021. 4) Sterility and Bacterial Endotoxins Electron-beam sterilization was evaluated in accordance with EN ISO 11137-2:2015 to support a Sterility Assurance Level of 10⁻⁶. Bacterial endotoxin testing was performed according to the applicable EP/USP requirements, with an acceptance criterion of less than 20 EU per device. 5) Biological Evaluation The biological safety evaluation was conducted in accordance with the following standards: • ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process • ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood • ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity • ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization • ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity {6} - ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation The biological evaluation included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogen, and hemocompatibility/hemolysis evaluations using a representative worst-case model. Clinical Data: Not Applicable The Safety Sterile Hypodermic Needles are substantially equivalent to the predicate device (Terumo SurGuard 3 Safety Hypodermic Needle). The non-clinical testing demonstrates that the device is as safe and effective as the legally marketed device. --- **Source:** [https://fda-staging.innolitics.com/device/K260933](https://fda-staging.innolitics.com/device/K260933) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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