# K242758: Atrauman® Ag

- Pathway: 510(k) (Traditional)
- Applicant: Hartmann USA, Inc.
- Decided: Dec 9, 2024 after 88 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
Longest line of descent: 6 generations back to K970566 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100430: Urgotul AG, Antimicrobial Wound Dressing with Silver, Laboratoires Urgo (2010) Summary page 5.

## Indications for use
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical graft donor sites, surgical wounds, and abrasions.

Source page: https://510kreport.com/device/K242758
Methodology: https://510kreport.com/methodology