Cleared Traditional

K151949 - Disposable Insulin Syringe

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

K151949 · Jiangyin Caina Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K151949

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.

FMF Device Classification - Class 2, Special Controls

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 489
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K151949.
SiO2 Coated syringe 3 ml
K153553 · Sio2 Medical Products · May 2016
HumanPen Ergo II
K151686 · Eli Lilly and Company, Inc. · Dec 2015
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
Intradermal Adapter
K151777 · West Pharmaceutical Services, Inc. · Sep 2015
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K150874 · Novo Nordisk, Inc. · Jul 2015