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
97–120 of 750
Cleared Dec 17, 2020
S dispensing line
K192770
Aea Srl
General Hospital · 444d
Cleared Dec 14, 2020
Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
K201284
Set Medikal Sanayi VE Ticaret Anonim Sirketi
General Hospital · 215d
Cleared Oct 16, 2020
ARTHROTAP
K201816
Accuro Technologies, Inc.
General Hospital · 107d
Cleared Sep 03, 2020
3D GraftRasp System
K201900
Surgentec
Orthopedic · 57d
Cleared Jul 17, 2020
Syringe with safety needle, Safety needle
K193526
Jiangsu Caina Medical Co.,Ltd
General Hospital · 211d
Cleared Jul 15, 2020
BD SoloShot Mini Syringe/ BD Auto Disable Syringe
K201234
Becton, Dickinson and Company
General Hospital · 69d
Cleared Jul 14, 2020
Orbit Subretinal Delivery System
K200325
Orbit Biomedical
Ophthalmic · 155d
Cleared Jul 13, 2020
Allograft MIS Delivery System
K201338
Lifenet Health
General & Plastic Surgery · 54d
Cleared May 29, 2020
Aspire Mechanical Aspirator G
K200629
Control Medical Technology
General Hospital · 80d
Cleared May 18, 2020
3D GraftRasp System
K200431
Surgentec
General & Plastic Surgery · 87d
Cleared May 01, 2020
O-Genesis Graft Delivery System
K200606
Orthofix, Inc.
General & Plastic Surgery · 53d
Cleared Mar 05, 2020
Omnifix Low Dead Space Luer Lock Syringe
K193101
B.Braun Medical, Inc.
General Hospital · 118d
Cleared Feb 18, 2020
Mixing and Delivery System
K192674
Bone Solutions, Inc.
General & Plastic Surgery · 145d
Cleared Jan 31, 2020
Tamper Evident Cap
K193192
International Medical Industries, Inc.
General Hospital · 73d
Cleared Jan 06, 2020
TK Sterile Piston Syringe without Needle
K191642
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital · 201d
Cleared Oct 21, 2019
BD Insulin Syringe
K190054
Becton, Dickinson and Company
General Hospital · 283d
Cleared Oct 10, 2019
Instylla Delivery Kit
K191659
Instylla, Inc.
General Hospital · 111d
Cleared Oct 09, 2019
Nipro Syringe
K191359
Nipro Medical Corporation
General Hospital · 141d
Cleared Sep 27, 2019
EpiFaith Syringe
K192421
Flat Medical Co., Ltd.
Anesthesiology · 23d
Cleared Sep 12, 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
K190002
Shanghai Kohope Medical Devices Co., Ltd.
General Hospital · 253d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531
Shina Med Corporation
General Hospital · 88d
Cleared Sep 03, 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
K182765
Top Corporation
General Hospital · 340d
Cleared Jul 28, 2019
Bonus Therapeutics Mixing and Delivery System
K190996
Bonus Therapeutics , Ltd.
Orthopedic · 103d
Cleared Jul 18, 2019
Immucise
K190427
Terumo Corporation
General Hospital · 146d