# K022416: Contreet Foam Adhesive/Non-Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Feb 3, 2003 after 194 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: 2 generations back to K946245 (1995). 5 ancestors in all.
32 later devices descend from it; 7 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983173: Biatain Foam Adhesive Dressing, Coloplast Corp. (1998) Summary page 1.
- K983163: Biatain Foam Dressing, Coloplast Corp. (1998) Summary page 1.
- K010447: Modification to Acticoat Foam Dressing, Westaim Biomedical, Inc. (2001)

## Most influential descendants
- 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
- K123961: Sentrex Biosponge MPD (2013), 4 descendants of its own

## Indications for use
The Contreet Foam is 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. Contreet Foam Non-adhesive is additionally indicated for diabetic foot ulcers.

Source page: https://510kreport.com/device/K022416
Methodology: https://510kreport.com/methodology