Cleared Traditional

Medline Safety Insulin and TB Syringes

K231907 · Medline Industries, LP · General Hospital
Oct 2023
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K231907 is an FDA 510(k) clearance for the Medline Safety Insulin and TB Syringes, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on October 18, 2023, 111 days after receiving the submission on June 29, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K231907 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2023
Decision Date October 18, 2023
Days to Decision 111 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
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
PowerPAK Syringe
K220114 · Vault Paragon Group, Inc. · Jan 2023