Cleared Traditional

K152339 - Unifine Pentips/ Unifine Pentips Plus

K152339 is an FDA 510(k) clearance for Unifine Pentips/ Unifine Pentips Plus, manufactured by Owen Mumford, Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K152339 · Owen Mumford, Ltd. · General Hospital
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Jun 2016
Decision
310d
Days
Class 2
Risk

K152339 is an FDA 510(k) clearance for the Unifine Pentips/ Unifine Pentips Plus. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on June 24, 2016 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Owen Mumford, Ltd. devices

FDA 510(k) Submission Details - K152339

510(k) Number K152339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2015
Decision Date June 24, 2016
Days to Decision 310 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
181d slower than avg
Panel avg: 129d · This submission: 310d
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 272
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K152339.
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K151398 · Terumo Europe N.V. · Jun 2015
K-Pack II Needle-21G x 2
K150263 · Terumo Europe N.V. · Apr 2015