# K840438: Comfeel Ulcus Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Nov 7, 1984 after 280 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K974348: Algoplaque Film Extra Thin Hydrocolloid Dressing (1998), 1 descendant of its own
- K082208: Doctors Choice Slow Healing Bandage with Spray on Remover (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K840438
Methodology: https://510kreport.com/methodology