# K090254: Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons, LLC
- Decided: Sep 4, 2009 after 214 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 K914604 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 1.

## Most influential descendants
- K102212: D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver (2011), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of: Partial thickness (second degree) bums; Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial and full thickness); Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intention such as dermatological and surgical incisions (e.g., orthopedic and vascular) Traumatic wounds Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma Management of painful wounds Infected wounds

Source page: https://510kreport.com/device/K090254
Methodology: https://510kreport.com/methodology