# K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons, LLC
- Decided: May 2, 2008 after 80 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 K914604 (1992). 5 ancestors in all.
54 later devices descend from it; 15 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943258: Hydrocolloid Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (1994) Summary page 1.
- K982116: Aquacel Hydrofiber Wound Dressing, Convatec, A Bristol-Myers Squibb Co. (1998) Summary page 1.
- K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2007) Summary page 1.

## Most influential descendants
- K122817: Silverlon Island Wound Dressing (2014), 13 descendants of its own
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber (2012), 13 descendants of its own
- K143001: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (2014), 5 descendants of its own
- K121522: Polyfit Absorbing Antimicrobial Dressings (Otc) (2012), 5 descendants of its own
- K183645: Silver High Performance Dressing (2019), 4 descendants of its own

## Indications for use
For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection - 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 & full thickness) - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions, - Surgical wounds that heal by primary intent 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 Wounds¹ For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and bums Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of: - Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers - Surgical wounds (post-operative, donor sites, dermatological) - Partial thickness (second degree) bums - Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions¹ - Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular)¹ - Traumatic wounds² - Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites - Management of painful wounds

Source page: https://510kreport.com/device/K080383
Methodology: https://510kreport.com/methodology