# K232655: Bonvadis®

- Pathway: 510(k) (Traditional)
- Applicant: Stemcyte, Inc.
- Decided: May 22, 2024 after 265 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 7 generations back to K830708 (1983). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212554: Bonvadis Topical Cream, Stemcyte, Inc. (2022) Summary page 6.
- K173549: Biafine, Valeant Pharmaceuticals (2018) Summary page 6.

## Most influential descendants
- K251093: Bonvadis® (2025), 1 descendant of its own
- K261638: Bonvadis® (2026), 0 descendants of its own

## Indications for use
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree bums.

Source page: https://510kreport.com/device/K232655
Methodology: https://510kreport.com/methodology