Cleared Traditional

K112332 - FINE JECT INSULIN PEN NEEDLE

K112332 is an FDA 510(k) clearance for FINE JECT INSULIN PEN NEEDLE, manufactured by Twobiens Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K112332 · Twobiens Co., Ltd. · General Hospital
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Jan 2012
Decision
151d
Days
Class 2
Risk

K112332 is an FDA 510(k) clearance for the FINE JECT INSULIN PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Twobiens Co., Ltd. (Pittsburgh, US). The FDA issued a Cleared decision on January 10, 2012 after a review of 151 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.

View all Twobiens Co., Ltd. devices

FDA 510(k) Submission Details - K112332

510(k) Number K112332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2011
Decision Date January 10, 2012
Days to Decision 151 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 slower than avg
Panel avg: 129d · This submission: 151d
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 K112332.
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K111797 · Terumo Europe N.V. · Sep 2011
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K110703 · Becton, Dickinson and Company · Jul 2011
K-PACK II NEEDLE- 27G & 30G THIN WALL
K110850 · Terumo Europe N.V. · Jun 2011