# K213716: InnovaBurn

- Pathway: 510(k) (Traditional)
- Applicant: Triad Life Sciences, Inc.
- Decided: Sep 29, 2022 after 309 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K061711 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193552: InnovaMatrix, Triad Life Sciences, Inc. (2020) Summary page 4.

## Indications for use
InnovaBurn™ is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), partial-thickness second degree burns, and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K213716
Methodology: https://510kreport.com/methodology