# K071936: Woundstat, Model TC1001

- Pathway: 510(k) (Traditional)
- Applicant: Traumacure, Inc.
- Decided: Aug 23, 2007 after 41 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: 2 generations back to K002550 (2000). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013390: Quickclot, On Site Gas Systems, Inc. (2002) Summary page 5.

## Most influential descendants
- K081183: Woundstat (2008), 1 descendant of its own
- K153138: Cerdak Basic (2017), 0 descendants of its own
- K082601: UltraClot, UltraClot OTC (2008), 0 descendants of its own

## Indications for use
WoundStatTM is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

Source page: https://510kreport.com/device/K071936
Methodology: https://510kreport.com/methodology