Cleared Traditional

K151949 - Disposable Insulin Syringe

K151949 is the FDA 510(k) clearance for Disposable Insulin Syringe by Jiangyin Caina Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K151949 · Jiangyin Caina Technology Co., Ltd. · General Hospital
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Oct 2015
Decision
79d
Days
Class 2
Risk

K151949 is an FDA 510(k) clearance for the Disposable Insulin Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangyin Caina Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 2, 2015 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jiangyin Caina Technology Co., Ltd. devices

Submission Details

510(k) Number K151949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2015
Decision Date October 02, 2015
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Peers - FMF Syringe, Piston

All 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K151949.
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014