Cleared Traditional

K113186 - STERILE INSULIN PEN NEEDLE

K113186 is an FDA 510(k) clearance for STERILE INSULIN PEN NEEDLE, manufactured by Shina Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K113186 · Shina Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
167d
Days
Class 2
Risk

K113186 is an FDA 510(k) clearance for the STERILE INSULIN PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Shina Corp. (Chungchengnam-Do, KR). The FDA issued a Cleared decision on April 12, 2012 after a review of 167 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

FDA 510(k) Submission Details - K113186

510(k) Number K113186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2011
Decision Date April 12, 2012
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 633
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K113186.
INSULIN PEN NEEDLE
K120690 · Tiger Medical Products, Ltd. · Jun 2012
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
K120661 · Vidacare Corporation · Jun 2012
PUSH-ON NEEDLE 30GX8MM
K120191 · Scandinavian Health Limited · May 2012
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
K113422 · Terumo (Philippines) Corporation · Mar 2012
SOL-M EXCHANGEABLE NEEDLES
K112777 · Sol-Milennium Medical, Inc. · Feb 2012
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
K113505 · Greiner Bio-One North America, Inc. · Feb 2012
K113186 · STERILE INSULIN PEN NEEDLE
Download PDF FDA Summary Shina Corp.