# K081183: Woundstat

- Pathway: 510(k) (Traditional)
- Applicant: Traumacure, Inc.
- Decided: Jun 19, 2008 after 55 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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: 3 generations back to K002550 (2000). 3 ancestors in all.
1 later device descends 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)
- K071936: Woundstat, Model TC1001, Traumacure, Inc. (2007) Summary page 5.

## Most influential descendants
- K082601: UltraClot, UltraClot OTC (2008), 0 descendants of its own

## Indications for use
WoundStatTM wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.

Source page: https://510kreport.com/device/K081183
Methodology: https://510kreport.com/methodology