# K943258: Hydrocolloid Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Aug 4, 1994 after 29 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K943258
Methodology: https://510kreport.com/methodology