Cleared Traditional

K192386 - KeraStat Cream

K192386 · Keranetics · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
317d
Days
-
Risk

K192386 is an FDA 510(k) clearance for the KeraStat Cream. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Keranetics (Winston Salem, US). The FDA issued a Cleared decision on July 16, 2020 after a review of 317 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.

View all Keranetics devices

Submission Details

510(k) Number K192386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date July 16, 2020
Days to Decision 317 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 84
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K192386.
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InnovaMatrix
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Symphony
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PELNAC Bilayer Wound Matrix
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Cytal Wound Matrix 3-Layer
K192725 · Acell, Inc. · Oct 2019