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
756 devices
97–120 of 756
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
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