# K973227: Askina Hydrocolloid/Thin

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 28, 1999 after 519 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 K881050 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881050: Duoderm (R) CGF, Convatec, A Division of E.R. Squibb & Sons (1988) Summary page 1.

## Indications for use
Askina Hydrocolloid and Askina Hydrocolloid/Thin react with a wound exudate to form a soft gel which permits dressing removal with minimal damage to newly formed tissue. It may be used for superficial wounds e.g. minor abrasions. It may also be used for the following indications under the supervision of a healthcare professional: Dermal Ulcers, including Partial & Full Thickness Wounds Pressure Ulcers, Stages I-IV Arterial and Venous Leg Ulcers Burns — Second Degree Donor Sites As an Aid in the Prevention of Skin Breakdown

Source page: https://510kreport.com/device/K973227
Methodology: https://510kreport.com/methodology