Cleared Traditional

K091167 - SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

K091167 is an FDA 510(k) clearance for SHINA INSULIN SYRINGE-INCLUDING ACCU-SU..., manufactured by Shina Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K091167 · Shina Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
106d
Days
Class 2
Risk

K091167 is an FDA 510(k) clearance for the SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shina Corp. (Seongnam-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on August 6, 2009 after a review of 106 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 Shina Corp. devices

FDA 510(k) Submission Details - K091167

510(k) Number K091167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2009
Decision Date August 06, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 354
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K091167.
COAXIAL APPLICATOR SYSTEM
K091722 · Biomet, Inc. · Mar 2010
ACACIA PISTON SYRINGE
K092986 · Acacia, Inc. · Oct 2009
NIPRO DISPOSABLE SYRINGE
K091279 · Nipro Medical Corporation · Aug 2009
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · Terumo Europe N.V. · May 2009
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · Covidien · Nov 2008