Cleared Traditional

K191490 - Retractable Safety Syringe

K191490 is the FDA 510(k) clearance for Retractable Safety Syringe by Jiangsu Caina Medical Co.,Ltd. It is a Class 2 General Hospital device (product code MEG) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K191490 · Jiangsu Caina Medical Co.,Ltd · General Hospital
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Oct 2019
Decision
120d
Days
Class 2
Risk

K191490 is an FDA 510(k) clearance for the Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable S.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on October 3, 2019 after a review of 120 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 Jiangsu Caina Medical Co.,Ltd devices

Submission Details

510(k) Number K191490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2019
Decision Date October 03, 2019
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
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 41
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K191490.
Retractable Safety Insulin Syringe
K193022 · Jiangsu Caina Medical Co.,Ltd · Jul 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
K192679 · Gemtier Medical (Shanghai), Inc. · Apr 2020
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
K190183 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Oct 2019
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
K183665 · Jiangsu Micsafe Medical Technology Co., Ltd. · Sep 2019
Greenmedi Safety Filter Syringe
K173743 · Sang-A Frontec Co., Ltd. · Jan 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018