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, Becton, Dickinson and Company and Promisemed Hangzhou Meditech Co., Ltd..

750
Total
750
Cleared
124d
Avg days
1976
Since
750 devices
25–48 of 750
Cleared Jun 18, 2024
Pen Injector
K240774
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 89d
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 Nov 30, 2023
NavaClick Injection System
K231877
Lineage Biomedical, Inc.
General Hospital · 157d
Cleared Nov 06, 2023
Revital Cady
K231519
Revital Healthcare (Epz) Limited
General Hospital · 165d
Cleared Nov 02, 2023
EpiZact
K233056
Guidestar Medical Devices
Anesthesiology · 38d
Cleared Oct 06, 2023
Disposable Sterile Syringe
K221777
Weihai Shengjie Medical Technology Co., Ltd.
General Hospital · 472d
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 Sep 08, 2023
Sterile Auto-Disable Syringes with/without Needle for Single Use
K231727
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Jul 25, 2023
A-TAP (previously called Arthrotap)
K231900
Elcam Medical Acal
General Hospital · 27d
Cleared Jul 18, 2023
Hypodermic Syringes & Needle
K222925
Lifelong Meditech Private Limited
General Hospital · 295d
Cleared Jul 17, 2023
Avitus® DragonWing Large Volume Autograft Delivery System
K231456
Avitus Orthopaedics, Inc.
Orthopedic · 59d
Cleared Jun 26, 2023
Avitus® Precision Autograft Delivery System
K230492
Avitus Orthopaedics, Inc.
General & Plastic Surgery · 123d
Cleared May 09, 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
K212857
Jiangsu Zhiyu Medical Instrument Co, Ltd.
General Hospital · 608d
Cleared May 04, 2023
Sol-Guard Auto-disable Syringe
K220713
Sol-Millennium Medical, Inc.
General Hospital · 419d
Cleared Apr 16, 2023
EpiFinder
K221974
Omeq Medical , Ltd.
Anesthesiology · 285d
Cleared Mar 23, 2023
Sterile Hypodermic Syringe for Single Use
K212207
Shandong Weigao Group Medical Polymer Co., Ltd.
General Hospital · 616d
Cleared Mar 06, 2023
Disposable Insulin Syringe
K222672
Hantech Medical Device Co., Ltd.
General Hospital · 181d
Cleared Mar 02, 2023
Insulin Syringe
K223453
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 106d