Cleared Traditional

K190002 - Sterile Hypodermic Syringe for Single use

K190002 is the FDA 510(k) clearance for Sterile Hypodermic Syringe for Single use by Shanghai Kohope Medical Devices Co., Ltd.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K190002 · Shanghai Kohope Medical Devices Co., Ltd. · General Hospital
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Sep 2019
Decision
253d
Days
Class 2
Risk

K190002 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insul.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shanghai Kohope Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 12, 2019 after a review of 253 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 Shanghai Kohope Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K190002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2019
Decision Date September 12, 2019
Days to Decision 253 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
124d slower than avg
Panel avg: 129d · This submission: 253d
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

Mid-Link Consulting Co, Ltd.
Diana Hong 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 - FMF Syringe, Piston

All 285
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