# K013814: Absorbent Antimicrobial Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Jun 21, 2002 after 217 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
No predicates in its family tree.
68 later devices descend from it; 12 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acticoat Silver Coated Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) (2004), 17 descendants of its own
- K041316: Antimicrobial Alginate Dressing (2004), 16 descendants of its own
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (2010), 11 descendants of its own
- K092689: Manukapli Wound Dressing (2010), 10 descendants of its own

## Indications for use
For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns, Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in 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 and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma. Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the DIRECTIONS FOR USE.

Source page: https://510kreport.com/device/K013814
Methodology: https://510kreport.com/methodology