Cleared Traditional

Sterile Syringe with Fixed Safety Needle for Single Use (K212652) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212652 · Gemtier Medical (Shanghai), Inc. · General Hospital
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Mar 2022
Decision
191d
Days
Class 2
Risk

K212652 is an FDA 510(k) clearance for the Sterile Syringe with Fixed Safety Needle for Single Use. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Gemtier Medical (Shanghai), Inc. (Shanghai, CN). The FDA issued a Cleared decision on March 2, 2022 after a review of 191 days - an extended review cycle.

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 Gemtier Medical (Shanghai), Inc. devices

Submission Details

510(k) Number K212652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2021
Decision Date March 02, 2022
Days to Decision 191 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
62d slower than avg
Panel avg: 129d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 - MEG Syringe, Antistick

All 38
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K212652.
Jeesung Safety Syringe and Single Use Needles
K212518 · Jeesung Medical Co., Ltd. · Aug 2022
Automatically Retractable Safety Syringe
K213077 · Zhejiang Lingyang Medical Apparatus Co., Ltd. · Apr 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216 · Shantou Wealy Medical Instrument Co.,Ltd · Mar 2022
Disposable Sterile Syringe with Safety Needle
K211484 · Shinva Ande Healthcare Apparatus Co., Ltd. · Mar 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. · Feb 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K210229 · Zhejiang Kangkang Medical-Devices Co., Ltd. · Feb 2022