Cleared Traditional

Foundation Dermal Regeneration Scaffold (DRS) Solo (K210949) - FDA 510(k) Clearance

K210949 · Bionova Medical, Inc. · General & Plastic Surgery device
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Aug 2022
Decision
499d
Days
-
Risk

K210949 is an FDA 510(k) clearance for the Foundation Dermal Regeneration Scaffold (DRS) Solo. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 499 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Bionova Medical, Inc. devices

Submission Details

510(k) Number K210949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2021
Decision Date August 11, 2022
Days to Decision 499 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
384d slower than avg
Panel avg: 115d · This submission: 499d
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 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K210949.
InnovaMatrix PD
K211902 · Triad Life Sciences, Inc. · Sep 2022
LUOFUCON Collagen Wound Dressing
K213598 · Huizhou Foryou Medical Devices Co., Ltd. · Sep 2022
Miro3D Wound Matrix
K221520 · Reprise Biomedical, Inc. · Aug 2022
PELNAC Meshed Bilayer Wound Matrix
K213498 · Gunze Limited · Jul 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
K220317 · Organogenesis, Inc. · Jul 2022
Kerecis Silicone
K213231 · Kerecis Limited · Jun 2022