# K231953: Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Mar 22, 2024 after 266 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 K914604 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec Limited (2018) Summary page 5.

## Indications for use
The product is indicated for use on moderate to highly exuding acute and chronic wounds such as: • Diabetic ulcers • Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology) • Pressure injuries (stage 2-4) • Traumatic wounds • Partial thickness (second degree) burns • Donor sites • Post-operative surgical wounds • Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi’s sarcoma, and angiosarcoma

Source page: https://510kreport.com/device/K231953
Methodology: https://510kreport.com/methodology