Cleared Traditional

K131176 - ROSS RU SKIN DISCONTINUITIES

K131176 · Biotd S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
382d
Days
-
Risk

K131176 is an FDA 510(k) clearance for the ROSS RU SKIN DISCONTINUITIES. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Biotd S.A. (Austin, US). The FDA issued a Cleared decision on May 12, 2014 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K131176

510(k) Number K131176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2013
Decision Date May 12, 2014
Days to Decision 382 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 115d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K131176.
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K133542 · Innovacyn, Inc. · Apr 2014