# K983163: Biatain Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Dec 16, 1998 after 97 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 K871166 (1987). 1 ancestor in all.
33 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871166: Allevyn Hydrophilic Polyurethane Dressing, Smith & Nephew, Inc. (1987) Summary page 1.

## Most influential descendants
- K022416: Contreet Foam Adhesive/Non-Adhesive (2003), 32 descendants of its own
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) (2004), 17 descendants of its own
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (2010), 11 descendants of its own
- K062559: Urgocell AG Antimicrobial Wound Dressing with Silver (2007), 6 descendants of its own
- K140954: Luofucon Silver PU Antibacterial Foam Dressing (2015), 5 descendants of its own

## Indications for use
The Biatain Foam Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

Source page: https://510kreport.com/device/K983163
Methodology: https://510kreport.com/methodology