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
49–72 of 750
Cleared Feb 25, 2023
CompuFlo Epidural Computer Controlled Anesthesia System
K221702
Milestone Scientific, Inc.
Anesthesiology · 257d
Cleared Feb 13, 2023
Sofjec
K212635
Hwajin Medical Co., Ltd.
General Hospital · 543d
Cleared Feb 09, 2023
Insulin syringe with integrated needle DL
K203211
Dlp Medical Products, Corp.
General Hospital · 832d
Cleared Feb 09, 2023
Sterile Syringes for Single Use
K223678
Shanghai Kindly Enterprise Development Group Co., Ltd.
General Hospital · 63d
Cleared Dec 09, 2022
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054
Medline Industries, Inc.
General Hospital · 443d
Cleared Nov 04, 2022
Medwell Technology Ltd Syringes, various sizes
K212764
Medwell Technology, Ltd.
General Hospital · 430d
Cleared Nov 03, 2022
Insulin Syringes without needle
K221045
Berpu Medical Technology Co., Ltd.
General Hospital · 209d
Cleared Oct 17, 2022
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K221308
Jiangxi Maidikang Medical Devices Co., Ltd.
General Hospital · 165d
Cleared Oct 11, 2022
Sol-M Luer Lock Syringe
K222744
Sol-Millennium Medical, Inc.
General Hospital · 29d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Needles
K221068
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use
K221079
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Aug 30, 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
K212846
Jiangsu Jichun Medical Devices Co., Ltd.
General Hospital · 357d
Cleared Aug 17, 2022
Disposable Sterile Syringe, with/without needle
K212033
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital · 414d
Cleared Aug 11, 2022
InstaFill Graft Delivery System, SIGNIFY Bioactive
K221737
Globus Medical, Inc.
General & Plastic Surgery · 57d
Cleared Jul 21, 2022
Syringe with permanently attached needle
K213158
Berpu Medical Technology Co., Ltd.
General Hospital · 296d
Cleared Jul 21, 2022
Pump Alignment Syringe
K220184
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Jul 14, 2022
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K220204
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital · 170d
Cleared May 12, 2022
Sterile Hypodermic Syringes for Single Use
K213811
Berpu Medical Technology Co., Ltd.
General Hospital · 156d
Cleared Apr 15, 2022
aboNT SYRINGE
K212677
Nipro Medical Corporation
General Hospital · 234d
Cleared Apr 05, 2022
Verifine Safety Syringe with Fixed Needle
K213560
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 147d
Cleared Mar 14, 2022
Qitexio
K203738
Medex
General Hospital · 447d
Cleared Mar 11, 2022
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
K212920
Shandong Weigao Group Medical Polymer Co., Ltd.
General Hospital · 178d
Cleared Mar 09, 2022
BD Insulin Syringe (0.3mL)
K212499
Becton, Dickinson and Company
General Hospital · 212d
Cleared Mar 01, 2022
Sure-Fine Insulin Syringes
K210848
Shina Med Corporation
General Hospital · 344d