# K983519: Comfeel Seasorb Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Dec 30, 1998 after 83 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953497 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K953497: Comfeel:Alginate Dressing, Coloplast A/S (1995) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Feb 14, 2007 · Not classified · Z-0710-2007: Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).

## Indications for use
The Comfeel® Seasorb Dressing is indicated for use (under the guidance of a health care professional) in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.

Source page: https://510kreport.com/device/K983519
Methodology: https://510kreport.com/methodology