# K982893: 3M Tegasorb Hydrocolloid Dressing

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 26, 1998 after 70 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
Longest line of descent: 1 generation back to K940624 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940624: 3M Tegasorb Hydrocolloid Dressing, 3M Company (1994) Summary page 1.

## Most influential descendants
- K033900: X-Static Silverseal Hydrocolloid Film and Island Dressing (2005), 2 descendants of its own
- K072378: Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625, AR-1626 (2007), 1 descendant of its own
- K083007: Prowick (2009), 0 descendants of its own

## Indications for use
The following conditions are considered appropriate for OTC use by the lay person: Superficial wounds such as cuts, lacerations, or abrasions First-degree burns The following conditions are considered appropriate for OTC use under the supervision of a health care professional: Partial or full thickness dermal ulcers Leg ulcers Second-degree burns Donor sites

Source page: https://510kreport.com/device/K982893
Methodology: https://510kreport.com/methodology