# K191536: Biatain Silicone Ag

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Feb 21, 2020 after 256 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: 6 generations back to K914579 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM, Coloplast A/S (2010) Summary page 4.

## Indications for use
Biatain® Silicone Ag is intended to provide a moist wound environment and exudate management of acute and chronic wounds. Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.

Source page: https://510kreport.com/device/K191536
Methodology: https://510kreport.com/methodology