Cleared Traditional

Verisafe Safety Retractable Insulin Syringes

K250192 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Dec 2025
Decision
321d
Days
Class 2
Risk

About This 510(k) Submission

K250192 is an FDA 510(k) clearance for the Verisafe Safety Retractable Insulin Syringes, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on December 10, 2025, 321 days after receiving the submission on January 23, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K250192 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2025
Decision Date December 10, 2025
Days to Decision 321 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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