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
73–96 of 750
Cleared Feb 10, 2022
Instylla Delivery Kit
K213632
Instylla, Inc.
General Hospital · 85d
Cleared Jan 27, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210
Azur Medical Company, Inc.
General Hospital · 279d
Cleared Jan 24, 2022
Disposable Syringe with Needle
K211482
Shandong Qinkai Medical Industry Co., Ltd.
General Hospital · 257d
Cleared Jan 18, 2022
CHIRANA Insulin Syringes
K201044
Chirana T. Injecta
General Hospital · 637d
Cleared Dec 17, 2021
Sterile Syringe for Single Use
K210914
Jiangsu Suyun Medical Material Co., Ltd.
General Hospital · 263d
Cleared Oct 13, 2021
MiniLoad Syringe
K212544
Ocuject, LLC
General Hospital · 62d
Cleared Oct 07, 2021
Sterile syringes for single use with/without needle
K211211
Azur Medical Company, Inc.
General Hospital · 167d
Cleared Oct 05, 2021
Sterile hypodermic syringes for single use
K211728
Jiangsu Kangyou Medical Instrument Co., Ltd.
General Hospital · 123d
Cleared Sep 15, 2021
TrueCare Biomedix Tamper Evident Cap
K210818
Us Infusion Inc. D/B/A Truecare Biomedix-USA
General Hospital · 181d
Cleared Sep 10, 2021
Sterile syringe for single use with/without needle
K210227
Zhejiang Kangkang Medical-Devices Co., Ltd.
General Hospital · 225d
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 Sep 07, 2021
PreferX Delivery System
K210997
Md3, LLC
General & Plastic Surgery · 158d
Cleared Aug 26, 2021
Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
K210991
Guangdong Antmed Co., Ltd.
General Hospital · 146d
Cleared Aug 24, 2021
Auto Disable Syringe
K210464
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital · 189d
Cleared Jul 28, 2021
BD Flu+ Syringe
K203359
Becton, Dickinson and Company
General Hospital · 254d
Cleared Jul 16, 2021
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
K210103
Lifelong Meditech Private Limited
General Hospital · 183d
Cleared May 14, 2021
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
K210200
Set Medikal Sanayi VE Ticaret Anonim Sirketi
General Hospital · 109d
Cleared Apr 26, 2021
MicroDose Injector
K203264
Medone Surgical, Inc.
Ophthalmic · 172d
Cleared Feb 19, 2021
MiniLoad Syringe
K202432
Ocuject, LLC
General Hospital · 178d
Cleared Jan 25, 2021
BD Hypodermic Syringe
K203453
Becton, Dickinson and Company
General Hospital · 63d
Cleared Jan 17, 2021
Nanum Syringe
K201930
Nanum Company Co., Ltd.
General & Plastic Surgery · 191d
Cleared Jan 07, 2021
Instylla Delivery Kit
K202544
Instylla, Inc.
General Hospital · 127d
Cleared Jan 05, 2021
Insulin Syringe
K193273
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 406d