Cleared Traditional

K151168 - Nexodyn AOS Wound Care Solution

K151168 · Apr Applied Pharma Research SA · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
235d
Days
-
Risk

K151168 is an FDA 510(k) clearance for the Nexodyn AOS Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Apr Applied Pharma Research SA (Balerna, CH). The FDA issued a Cleared decision on December 22, 2015 after a review of 235 days - an extended review cycle.

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. Standard predicate reliance. 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 - K151168

510(k) Number K151168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date December 22, 2015
Days to Decision 235 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
120d slower than avg
Panel avg: 115d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Donawa Lifescience Consulting Srl
Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K151168.
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Next Science Wound Gel
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Alevicyn SG Antipruritic Gel
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