# K083113: Acticoat Flex 7 Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 22, 2009 after 274 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: 3 generations back to K914579 (1992). 6 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 2.
- K001519: Acticoat 7 Dressing, Westaim Biomedical, Inc. (2000)

## Most influential descendants
- K122817: Silverlon Island Wound Dressing (2014), 13 descendants of its own
- K143001: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (2014), 5 descendants of its own
- K150256: Silverlon Burn Contact Dressings (2015), 4 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

## Indications for use
ACTICOAT FLEX 7 is indicated for use on partial and full thickness wounds for up to 7 days. This includes: first and second-degree bums, as a protective covering of grafts, surgical sites, venous ulcers, pressure ulcers, diabetic ulcers.

Source page: https://510kreport.com/device/K083113
Methodology: https://510kreport.com/methodology