FMF · Class II · 21 CFR 880.5860

FDA Product Code FMF: Syringe, Piston

Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.

These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.

FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Sherwood Medical Co. and Becton, Dickinson and Company.

756
Total
756
Cleared
124d
Avg days
1976
Since
Declining activity - 25 submissions in the last 2 years vs 40 in the prior period
Review times increasing: avg 168d recently vs 123d historically

FDA 510(k) Cleared Syringe, Piston Devices (Product Code FMF)

756 devices
1–24 of 756
Cleared Aug 26, 2026
GraftGun Universal Graft Delivery System (GDS®)
K262581
SurGenTec, LLC
Orthopedic · 30d
Cleared Aug 25, 2026
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
K252184
Sol-Millennium Medical, Inc.
General Hospital · 410d
Cleared Aug 14, 2026
Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
K253747
Jiangsu Enjosim Medical Technology Co., Ltd.
General Hospital · 262d
Cleared Jul 13, 2026
Ultra-Fine™ SAFETY Insulin Syringe
K260208
embecta Medical II, LLC
General Hospital · 171d
Cleared Jun 18, 2026
Sol-Glide Safety Needle
K253110
Sol-Millennium Medical, Inc.
General Hospital · 267d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared May 21, 2026
Sofjec (Single use Needle)
K253112
Hlb Lifescience Co., Ltd.
General Hospital · 239d
Cleared Apr 17, 2026
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
K252279
Chirana T.Injecta,A.S.
General Hospital · 269d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Dec 22, 2025
Instylla Delivery Kit
K253769
Instylla, Inc.
General Hospital · 27d
Cleared Dec 17, 2025
DuoprossTM Smart Cap (Type I)
K252518
Duopross Meditech Corporate
General Hospital · 128d
Cleared Dec 12, 2025
EXEL Disposable Syringe
K251089
Exelint International, Co.
General Hospital · 246d
Cleared Dec 10, 2025
Verisafe Safety Retractable Insulin Syringes
K250192
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 321d
Cleared Nov 04, 2025
Merit Syringe
K250853
Merit Medical Systems, Inc.
General Hospital · 228d
Cleared Oct 15, 2025
Sure-Fine Insulin Syringes
K250510
Shina Med Corporation
General Hospital · 236d
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660
Cardinalhealth
General Hospital · 268d
Cleared Jul 29, 2025
BD Plastipak™ Syringe
K251350
Becton, Dickinson and Company
General Hospital · 90d
Cleared Jul 25, 2025
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
K252033
CMT Health PTE., Ltd.
General Hospital · 25d
Cleared Jul 03, 2025
3DOSE 1ml Syringe
K250733
Bimed Teknik Aletler Sanayi & Ticaret A.S.
General Hospital · 114d
Cleared Jun 24, 2025
GPS Advanced
K251648
Prosidyan, Inc.
Orthopedic · 26d
Cleared Apr 24, 2025
GO-PEN®
K250262
Go-Pen Aps
General Hospital · 85d
Cleared Feb 05, 2025
GraftGun Universal Graft Delivery System (GDS)
K243580
SurGenTec, LLC
Orthopedic · 78d
Cleared Dec 24, 2024
Insulin Syringes
K242434
Chirana T. Injecta
General Hospital · 130d
Cleared Dec 23, 2024
Sofjec (Single use Needle)
K241856
Hlb Lifescience Co., Ltd.
General Hospital · 179d

About Product Code FMF - Regulatory Context

510(k) Submission Activity

756 total 510(k) submissions under product code FMF since 1976, with 756 receiving FDA clearance (average review time: 124 days).

Submission volume has declined in recent years - 25 submissions in the last 24 months compared to 40 in the prior period.

FDA 510(k) Review Time - FMF Product Code

Recent submissions under FMF have taken an average of 168 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.

FMF devices are reviewed by the General Hospital panel. Browse all General Hospital devices →