FMF
- Product code
- FMF
- Device name
- Syringe, Piston
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 43
- Summaries archived here
- 36 (direct download)
- 510(k) clearances (all years, FDA)
- 752 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (43)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262581 | 2026-08-26 | SurGenTec, LLC | GraftGun Universal Graft Delivery System (GDS®) | |
| K252184 | 2026-08-25 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe with Exchangeable Needle Tra… | |
| K253747 | 2026-08-14 | Jiangsu Enjosim Medical Technology Co.… | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | |
| K260208 | 2026-07-13 | embecta Medical II, LLC | Ultra-Fine SAFETY Insulin Syringe | FDA |
| K253110 | 2026-06-18 | Sol-Millennium Medical, Inc. | Sol-Glide Safety Needle; Sol-Glide Safety Needle wit… | |
| K260514 | 2026-06-12 | CMT Health PTE., Ltd. | Profoject Safety Needle; Profoject Syringe with Sa… | |
| K253112 | 2026-05-21 | Hlb Lifescience Co., Ltd. | Sofjec (Single use Needle); Sofjec (Single use Syrin… | |
| K252279 | 2026-04-17 | Chirana T.Injecta,A.S. | Sterile Hypodermic Syringe for Single Use (20ml, 30m… | FDA |
| K253068 | 2026-02-23 | CMT Health PTE., Ltd. | Profoject Insulin Syringes; Profoject Safelock Dis… | |
| K253769 | 2025-12-22 | Instylla, Inc. | Instylla Delivery Kit | |
| K252518 | 2025-12-17 | Duopross Meditech Corporate | DuoprossTM Smart Cap (Type I) | |
| K251089 | 2025-12-12 | Exelint International, Co. | EXEL Disposable Syringe; EXEL Disposable Syringe wit… | |
| K250192 | 2025-12-10 | Promisemed Hangzhou Meditech Co., Ltd. | Verisafe Safety Retractable Insulin Syringes | FDA |
| K250853 | 2025-11-04 | Merit Medical Systems, Inc. | Merit Syringe | |
| K250510 | 2025-10-15 | Shina Med Corporation | Sure-Fine Insulin Syringes | |
| K243660 | 2025-08-22 | Cardinalhealth | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (118… | — |
| K251350 | 2025-07-29 | Becton, Dickinson and Company | BD Plastipak Syringe | |
| K252033 | 2025-07-25 | CMT Health PTE., Ltd. | Profoject Disposable Syringe, Profoject Disposable… | |
| K250733 | 2025-07-03 | Bimed Teknik Aletler Sanayi & Ticaret … | 3DOSE 1ml Syringe | |
| K251648 | 2025-06-24 | Prosidyan, Inc. | GPS Advanced; GPS Advanced Cannula | |
| K250262 | 2025-04-24 | Go-Pen Aps | GO-PEN® | |
| K243580 | 2025-02-05 | SurGenTec, LLC | GraftGun Universal Graft Delivery System (GDS) | FDA |
| K242434 | 2024-12-24 | Chirana T. Injecta | Insulin Syringes | |
| K241856 | 2024-12-23 | Hlb Lifescience Co., Ltd. | Sofjec (Single use Needle); Sofjec (Single use Syrin… | |
| K242099 | 2024-10-22 | Sol-Millennium Medical, Inc. | Sol-M Slip Tip Syringe without Needle, Sol-M Eccen… | |
| K241821 | 2024-09-20 | Sol-Millennium Medical, Inc. | Luer Lock Syringe with Safety Needle; Luer Lock Syri… | |
| K231095 | 2024-09-04 | International Medical Industries, Inc. | Tamper Evident Cap | |
| K240961 | 2024-08-15 | Wuxi Nest Biotechnology Co., Ltd. | Disposable Pen Injector Assembly | |
| K241426 | 2024-07-10 | Prosidyan, Inc. | GPS Advanced; 5 cc GPS Advanced Cannula | |
| K233368 | 2024-06-25 | Bioventus, LLC | Allograft Delivery Device (OFAC-C) | |
| K240774 | 2024-06-18 | Wuxi Nest Biotechnology Co., Ltd. | Pen Injector | |
| K232950 | 2024-06-12 | Perfect Medical Industry (Vn) Co., Ltd… | Sterile Disposable Syringe, Sterile Disposable Syrin… | FDA |
| K234024 | 2024-03-19 | Anhui Hongyu Wuzhou Medical Manufactur… | HWJECT Auto-disable syringe | |
| K233794 | 2024-03-06 | Spm Medicare Pvt. , Ltd. | Insulin Syringe | |
| K230235 | 2024-02-16 | Medline Industries, LP | Medline Luer Lock Syringes | |
| K231558 | 2024-01-12 | Smb Corporation of India | SMB Luer lock disposable syringe | |
| K230061 | 2023-11-30 | Anhui Hongyu Wuzhou Medical Manufactur… | Insulin Syringe | |
| K231877 | 2023-11-30 | Lineage Biomedical, Inc. | NavaClick Injection System | |
| K231519 | 2023-11-06 | Revital Healthcare (Epz) Limited | Revital Cady | |
| K233056 | 2023-11-02 | Guidestar Medical Devices | EpiZact | |
| K221777 | 2023-10-06 | Weihai Shengjie Medical Technology Co.… | Disposable Sterile Syringe | |
| K231792 | 2023-09-28 | Promisemed Hangzhou Meditech Co., Ltd. | VeriSafe Safety sterile syringes | FDA |
| K231888 | 2023-09-25 | Care Fusion | BD Texium Needle-Free Syringe |
Official FDA classification page: FMF
Classification and pathway per current FDA publications. Data from openFDA (CC0).