# K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons, LLC
- Decided: Apr 16, 2007 after 168 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 K914604 (1992). 2 ancestors in all.
59 later devices descend from it; 5 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984371: Mepitel Non Adherent Silicone Dressing, Molnlycke Health Care, Inc. (1999) Summary page 1.

## Most influential descendants
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing (2008), 54 descendants of its own
- 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

## 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 health care professional, Aquacel may be used for the management of. leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers surgical wounds (post-operative, donor sites, dermatological) second degree burns Aquacel may also be used for: management of surgical or traumatic wounds that have been left to heal by secondary intention. local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds. the management of painful wounds For over-the-counter use, Aquacel-Ag may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns Under the supervision of a health care professional, Aquacel-Ag may be used for the management of. - wounds as an effective barrier to bacterial penetration to help reduce infection; - partial thickness (second degree) burns; - diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness); - surgical wounds left to heal by secondary intent; - traumatic wounds; - wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided; - oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma. - the management of painful wounds Aquacel Ag may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE.

Source page: https://510kreport.com/device/K063271
Methodology: https://510kreport.com/methodology