# K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Feb 17, 2010 after 22 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: 5 generations back to K914579 (1992). 20 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022416: Contreet Foam Adhesive/Non-Adhesive, Coloplast Corp. (2003) Summary page 2.
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.), Coloplast Corp. (2004) Summary page 2.

## Most influential descendants
- K140954: Luofucon Silver PU Antibacterial Foam Dressing (2015), 5 descendants of its own
- K160022: LUOFUCON Silicone Ag foam dressing (2016), 3 descendants of its own
- K170077: LUOFUCON Silicone Ag Foam Dressing with Border (2017), 2 descendants of its own
- K120828: Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches (2012), 2 descendants of its own
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own

## Indications for use
Biatain Ag Foam Adhesive & Non-Adhesive Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions. Biatain Ag Foam Non-Adhesive Dressings are additionally indicated for diabetic foot ulcers. Biatain Ag Foam Cavity Dressings are indicated for deep wounds with moderate to high amounts of exudate. Biatain Ag Foam Cavity Dressings are indicated for stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.

Source page: https://510kreport.com/device/K100218
Methodology: https://510kreport.com/methodology