# K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Inc.
- Decided: Jul 25, 2012 after 89 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.
13 later devices descend from it; 6 cite it directly.
0 of 20 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
- K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (2018), 4 descendants of its own
- K210718: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing (2022), 2 descendants of its own
- K172570: ALGS6 Ag Alginate Wound Dressing (2018), 2 descendants of its own
- K173844: Titan Ag 200 (2018), 1 descendant of its own
- K252167: Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (2025), 0 descendants of its own

## Indications for use
For Over-the-Counter Use: AQUACEL Ag EXTRA Hydrofiber Dressing with Silver and Strengthening Fiber may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional: AQUACEL Ag EXTRA Hydrofiber Dressing with Silver and Strengthening Fiber 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) burns; - 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 dlehisced 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 surgicaliy debrided and donor sites; - Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; - Painful wounds; - Infected wounds

Source page: https://510kreport.com/device/K121275
Methodology: https://510kreport.com/methodology