Cleared Traditional

K213560 - Verifine Safety Syringe with Fixed Needle

K213560 is the FDA 510(k) clearance for Verifine Safety Syringe with Fixed Needle by Promisemed Hangzhou Meditech Co., Ltd.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K213560 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
147d
Days
Class 2
Risk

K213560 is an FDA 510(k) clearance for the Verifine Safety Syringe with Fixed Needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on April 5, 2022 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K213560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2021
Decision Date April 05, 2022
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Vee Care (Asia) Limited
Wei Shan Hsu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K213560.
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
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aboNT SYRINGE
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K203738 · Medex · Mar 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
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