Cleared Traditional

Bonvadis Topical Cream (K212554) - FDA 510(k) Clearance

K212554 · Stemcyte, Inc. · General & Plastic Surgery device
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Aug 2022
Decision
371d
Days
-
Risk

K212554 is an FDA 510(k) clearance for the Bonvadis Topical Cream. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Stemcyte, Inc. (Baldwin Park, US). The FDA issued a Cleared decision on August 19, 2022 after a review of 371 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 Stemcyte, Inc. devices

Submission Details

510(k) Number K212554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2021
Decision Date August 19, 2022
Days to Decision 371 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 115d · This submission: 371d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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