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 Promisemed Hangzhou Meditech Co., Ltd., Becton, Dickinson and Company and Sol-Millennium Medical, Inc..

749
Total
749
Cleared
124d
Avg days
1976
Since
749 devices
25–48 of 749
Cleared Jun 12, 2024
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
K232950
Perfect Medical Industry (Vn) Co., Ltd.
General Hospital · 266d
Cleared Mar 19, 2024
HWJECT Auto-disable syringe
K234024
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
General Hospital · 90d
Cleared Mar 06, 2024
Insulin Syringe
K233794
Spm Medicare Pvt. , Ltd.
General Hospital · 99d
Cleared Feb 16, 2024
Medline Luer Lock Syringes
K230235
Medline Industries, LP
General Hospital · 385d
Cleared Jan 12, 2024
SMB Luer lock disposable syringe
K231558
Smb Corporation of India
General Hospital · 227d
Cleared Nov 30, 2023
Insulin Syringe
K230061
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
General Hospital · 325d
Cleared Sep 28, 2023
VeriSafe Safety sterile syringes
K231792
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 100d
Cleared Sep 25, 2023
BD Texium™ Needle-Free Syringe
K231888
Care Fusion
General Hospital · 90d
Cleared Jul 25, 2023
A-TAP (previously called Arthrotap)
K231900
Elcam Medical Acal
General Hospital · 27d
Cleared May 04, 2023
Sol-Guard Auto-disable Syringe
K220713
Sol-Millennium Medical, Inc.
General Hospital · 419d
Cleared Mar 02, 2023
Insulin Syringe
K223453
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 106d
Cleared Dec 09, 2022
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054
Medline Industries, Inc.
General Hospital · 443d
Cleared Aug 11, 2022
InstaFill Graft Delivery System, SIGNIFY Bioactive
K221737
Globus Medical, Inc.
General & Plastic Surgery · 57d
Cleared Jul 21, 2022
Pump Alignment Syringe
K220184
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Apr 15, 2022
aboNT SYRINGE
K212677
Nipro Medical Corporation
General Hospital · 234d
Cleared Apr 05, 2022
Verifine Safety Syringe with Fixed Needle
K213560
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 147d
Cleared Mar 09, 2022
BD Insulin Syringe (0.3mL)
K212499
Becton, Dickinson and Company
General Hospital · 212d
Cleared Sep 09, 2021
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 136d
Cleared Sep 08, 2021
Verifine Mechanical Safety Insulin Syringe
K210712
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 182d
Cleared Jul 28, 2021
BD Flu+ Syringe
K203359
Becton, Dickinson and Company
General Hospital · 254d
Cleared Jan 25, 2021
BD Hypodermic Syringe
K203453
Becton, Dickinson and Company
General Hospital · 63d
Cleared Jan 05, 2021
Insulin Syringe
K193273
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 406d