Cleared Traditional

K123904 - PROTHELIAL

K123904 · Mueller Medical International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
231d
Days
-
Risk

K123904 is an FDA 510(k) clearance for the PROTHELIAL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Mueller Medical International, LLC (Foster, US). The FDA issued a Cleared decision on August 7, 2013 after a review of 231 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 - K123904

510(k) Number K123904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date August 07, 2013
Days to Decision 231 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 115d · This submission: 231d
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 649
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K123904.
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K123904 · PROTHELIAL
Download PDF FDA Summary Mueller Medical Inter…