Cleared Traditional

K120690 - INSULIN PEN NEEDLE

K120690 is an FDA 510(k) clearance for INSULIN PEN NEEDLE, manufactured by Tiger Medical Products, Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K120690 · Tiger Medical Products, Ltd. · General Hospital
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Jun 2012
Decision
107d
Days
Class 2
Risk

K120690 is an FDA 510(k) clearance for the INSULIN PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Tiger Medical Products, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 22, 2012 after a review of 107 days - within the typical 510(k) review window.

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.

View all Tiger Medical Products, Ltd. devices

FDA 510(k) Submission Details - K120690

510(k) Number K120690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2012
Decision Date June 22, 2012
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 322
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K120690.
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THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
K120661 · Vidacare Corporation · Jun 2012
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K111797 · Terumo Europe N.V. · Sep 2011
BD AUTOSHIELD DUO PEN NEEDLE
K110703 · Becton, Dickinson and Company · Jul 2011