# K261638: Bonvadis®

- Pathway: 510(k) (Special)
- Applicant: Oneness Biotech Co., Ltd.
- Decided: Jun 17, 2026 after 30 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: 9 generations back to K830708 (1983). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251093: Bonvadis®, Oneness Biotech Co., Ltd. (2025) Summary page 5.

## Indications for use
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.

Source page: https://510kreport.com/device/K261638
Methodology: https://510kreport.com/methodology