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
145–168 of 756
Cleared Mar 27, 2017
Freedom Syringe
K161812
Procedure Products, Inc.
General Hospital · 269d
Cleared Mar 20, 2017
Sterile Single-use Syringe with Needle
K163161
Jiangxi Hongda Medical Equipment Group , Ltd.
General Hospital · 130d
Cleared Feb 24, 2017
Vesco Medical NRFit Tip Syringes
K170218
Vesco Medical, LLC
General Hospital · 30d
Cleared Feb 10, 2017
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K161606
Terumo Europe N.V.
General Hospital · 245d
Cleared Jan 11, 2017
ConceptoMed Luer-Jack Slip 10ml
K162057
Conceptomed AS
General Hospital · 169d
Cleared Dec 29, 2016
Disposable Insulin Syringe
K162180
Berpu Medical Technology Co., Ltd.
General Hospital · 147d
Cleared Dec 19, 2016
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081
Becton, Dickinson and Company
General Hospital · 145d
Cleared Oct 18, 2016
NovoPen Echo
K162602
Novo Nordisk, Inc.
General Hospital · 29d
Cleared Sep 16, 2016
Bone Solutions Mixing and Delivery System
K161568
Bone Solutions, Inc.
General Hospital · 101d
Cleared Sep 09, 2016
Sure-Fine Insulin Syringes
K152879
Shina Med Corporation
General Hospital · 345d
Cleared Jul 26, 2016
InPen
K160629
Companion Medical, Inc.
General Hospital · 141d
Cleared Jul 12, 2016
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
K152803
Sung Shim Medicare Co., Ltd.
General Hospital · 288d
Cleared Jul 08, 2016
BD U-500 INSULIN SYRINGE
K151870
Becton, Dickinson and Company
General Hospital · 365d
Cleared Jul 08, 2016
LITe BIO Delivery System
K160978
Stryker Corporation
General Hospital · 92d
Cleared Jun 17, 2016
Sol-M Insulin Syringe, Sol-M TB Syringe
K153537
Sol-Millennium Medical, Inc.
General Hospital · 190d
Cleared Jun 03, 2016
HumaPen Savvio
K160668
Eli Lilly and Company, Inc.
General Hospital · 86d
Cleared May 17, 2016
SiO2 Coated syringe 3 ml
K153553
Sio2 Medical Products
General Hospital · 158d
Cleared Dec 30, 2015
HumanPen Ergo II
K151686
Eli Lilly and Company, Inc.
General Hospital · 190d
Cleared Dec 07, 2015
Merit 20 mL Syringe
K152783
Merit Medical Systems, Inc.
General Hospital · 73d
Cleared Oct 02, 2015
Disposable Insulin Syringe
K151949
Jiangyin Caina Technology Co., Ltd.
General Hospital · 79d
Cleared Sep 29, 2015
Intradermal Adapter
K151777
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Sep 02, 2015
BD Single Use, Hypodermic Syringe
K151766
Becton, Dickinson and Company
General Hospital · 64d
Cleared Jul 31, 2015
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K150874
Novo Nordisk, Inc.
General Hospital · 121d
Cleared Jul 07, 2015
Graft Delivery Device with Integrated Stylet
K151543
Micromedics, Inc. (D/B/A Nordson Medical)
General Hospital · 29d