# K953497: Comfeel:Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Sep 29, 1995 after 65 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K983519: Comfeel Seasorb Dressing (1998), 2 descendants of its own
- K102942: Coreleader Algiplaster Model AP 050501 (2011), 0 descendants of its own
- K102943: Coreleader Algi-Fiber Wound Dressing Model Adw 05050 (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K953497
Methodology: https://510kreport.com/methodology