MEG · Class II · 21 CFR 880.5860

FDA Product Code MEG: Syringe, Antistick

Leading manufacturers include Jiangsu Caina Medical Co.,Ltd, Smiths Medical Asd, Inc. and Gemtier Medical (Shanghai), Inc..

163
Total
163
Cleared
170d
Avg days
1994
Since
Declining activity - 2 submissions in the last 2 years vs 12 in the prior period
Review times increasing: avg 249d recently vs 169d historically

FDA 510(k) Cleared Syringe, Antistick Devices (Product Code MEG)

163 devices
1–24 of 163
Cleared Feb 18, 2026
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098
Methyl Co., Ltd.
General Hospital · 230d
Cleared Dec 12, 2025
VaporShield
K250847
Vault Paragon Group, Inc.
General Hospital · 267d
Cleared Nov 21, 2023
SaviSafe Safety Device
K230287
Suzhou Savicred Biotechnology Co., Ltd.
General Hospital · 292d
Cleared Oct 27, 2023
Shina Syringe
K231165
Shina Med Corporation
General Hospital · 185d
Cleared Oct 18, 2023
Medline Safety Insulin and TB Syringes
K231907
Medline Industries, LP
General Hospital · 111d
Cleared Jun 21, 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376
Cardinal Health200, LLC
General Hospital · 229d
Cleared Jan 25, 2023
PowerPAK Syringe
K220114
Vault Paragon Group, Inc.
General Hospital · 376d
Cleared Dec 29, 2022
SafeR Syringe and SafeR Sting
K221981
Roncadelle Operations Srl
General Hospital · 177d
Cleared Nov 23, 2022
Disposable Automatically Retractable Safety Syringes (with detachable needle)
K222452
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 100d
Cleared Nov 01, 2022
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
K221247
Jiangsu Kangbao Medical Equipment Co., Ltd.
General Hospital · 183d
Cleared Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
K220057
Shinva Ande Healthcare Apparatus Co., Ltd.
General Hospital · 274d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Safety Needles
K221073
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Aug 23, 2022
Safety Insulin Syringes
K220061
Berpu Medical Technology Co., Ltd.
General Hospital · 225d
Cleared Aug 18, 2022
Jeesung Safety Syringe and Single Use Needles
K212518
Jeesung Medical Co., Ltd.
General Hospital · 373d
Cleared Apr 27, 2022
Automatically Retractable Safety Syringe
K213077
Zhejiang Lingyang Medical Apparatus Co., Ltd.
General Hospital · 216d
Cleared Mar 04, 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 401d
Cleared Mar 02, 2022
Sterile Syringe with Fixed Safety Needle for Single Use
K212652
Gemtier Medical (Shanghai), Inc.
General Hospital · 191d
Cleared Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
K211484
Shinva Ande Healthcare Apparatus Co., Ltd.
General Hospital · 293d
Cleared Feb 24, 2022
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
K212949
Henan Nursecare Biotechnology Co., Ltd.
General Hospital · 161d
Cleared Feb 15, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K210229
Zhejiang Kangkang Medical-Devices Co., Ltd.
General Hospital · 383d
Cleared Nov 15, 2021
Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
K211329
Jiangsu Kangbao Medical Equipment Co., Ltd.
General Hospital · 196d
Cleared Oct 18, 2021
Hypodermic Safety Needle
K211555
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
General Hospital · 152d
Cleared Oct 14, 2021
Sterile Syringe With Safety Needle
K211753
Jiangxi Hongda Medical Equipment Group , Ltd.
General Hospital · 129d
Cleared Sep 29, 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 75d

About Product Code MEG - Regulatory Context

510(k) Submission Activity

163 total 510(k) submissions under product code MEG since 1994, with 163 receiving FDA clearance (average review time: 170 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 12 in the prior period.

FDA 510(k) Review Time - MEG Product Code

Recent submissions under MEG have taken an average of 249 days to reach a decision - up from 169 days historically. Manufacturers should account for longer review timelines in current project planning.

MEG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →