# K153565: Donasorb Silver Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Virchow Biotech Pvt, Ltd.
- Decided: Sep 22, 2016 after 283 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: 1 generation back to K991818 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991818: Acryderm Silver Anti-Microbial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045, Acrymed, Inc. (2000) Summary page 5.

## Indications for use
OTC: DONASORB™ is intended for use in management of mincr cuts, minor abrasions, minor lacerations and minor burns. Rx: DONASORB™ is intended for use by prescription for the management of partial and full thickness wounds such as pressure ulcers, vascular ulcers, diabetic wounds, lacerations, abrasions, surgical wounds, graft sites, skin tears, and first and second degree burns. DONASORB™ is not indicated for use on third degree burns.

Source page: https://510kreport.com/device/K153565
Methodology: https://510kreport.com/methodology