# K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: May 17, 2004 after 157 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: 4 generations back to K914579 (1992). 19 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 37 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.
- K024298: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2003) Summary page 2.
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002)
- K984210: Silverlon Wound Packing Strips, Argentum International, LLC (1999) Summary page 2.

## Most influential descendants
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (2010), 11 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
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo (2022), 3 descendants of its own
- K160022: LUOFUCON Silicone Ag foam dressing (2016), 3 descendants of its own

## Indications for use
Contreet Foam Cavity Dressing with Silver dressings are indicated for deep wounds with moderate to high amounts of exudate. Contreet Foam Cavity Dressing with Silver is indicated for stage II,III and IVpressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.

Source page: https://510kreport.com/device/K033869
Methodology: https://510kreport.com/methodology