Cleared Traditional

K141637 - SPB SKIN EMULSION

K141637 · 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
Jun 2015
Decision
349d
Days
-
Risk

K141637 is an FDA 510(k) clearance for the SPB SKIN EMULSION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Biotd S.A. (Austin, US). The FDA issued a Cleared decision on June 3, 2015 after a review of 349 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 - K141637

510(k) Number K141637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2014
Decision Date June 03, 2015
Days to Decision 349 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
234d slower than avg
Panel avg: 115d · This submission: 349d
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 K141637.
PROTOCOL Incision Dressing
K142962 · Deroyal Industries · Jul 2015
MEDIHONEY WOUND DRESSINGS
K133279 · Derma Sciences, Inc. · Jun 2015
Alevicyn SG Antipruritic Gel
K143590 · Oculus Innovative Sciences · Jun 2015
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
K143335 · Roosin Medical Devices Co., Ltd. · Jun 2015
PURICORE WOUND HYDROGEL SPRAY DRESSING
K141863 · Puricore, Inc. · May 2015
DERMAFINE
K140905 · Invado Pharmaceuticals · May 2015