Cleared Traditional

Retractable Safety Insulin Syringe

K193022 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Jul 2020
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K193022 is an FDA 510(k) clearance for the Retractable Safety Insulin Syringe, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on July 20, 2020, 264 days after receiving the submission on October 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K193022 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2019
Decision Date July 20, 2020
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

Similar Devices — MEG Syringe, Antistick

All 162
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · Methyl Co., Ltd. · Feb 2026
VaporShield
K250847 · Vault Paragon Group, Inc. · Dec 2025
SaviSafe Safety Device
K230287 · Suzhou Savicred Biotechnology Co., Ltd. · Nov 2023
Shina Syringe; Shina Safety Syringe
K231165 · Shina Med Corporation · Oct 2023
Medline Safety Insulin and TB Syringes
K231907 · Medline Industries, LP · Oct 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
K223376 · Cardinal Health200, LLC · Jun 2023