Cleared Traditional

InnovaBurn (K213716) - FDA 510(k) Clearance

K213716 · Triad Life Sciences, Inc. · General & Plastic Surgery device
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Sep 2022
Decision
309d
Days
-
Risk

K213716 is an FDA 510(k) clearance for the InnovaBurn. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Triad Life Sciences, Inc. (Memphis, US). The FDA issued a Cleared decision on September 29, 2022 after a review of 309 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 Triad Life Sciences, Inc. devices

Submission Details

510(k) Number K213716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2021
Decision Date September 29, 2022
Days to Decision 309 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
194d slower than avg
Panel avg: 115d · This submission: 309d
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 K213716.
NovoGen Wound Matrix
K220498 · Novabone Products, LLC · Jun 2023
FortiShield (Biosynthetic Wound Matrix)
K212579 · Organogenesis, Inc. · May 2023
Miro3D Wound Matrix
K223257 · Reprise Biomedical · Nov 2022
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