# K080648: Traumastat Rapid Hemostatic Wound Dressing Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Ore-Medix, LLC
- Decided: May 7, 2008 after 61 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: 6 generations back to K002550 (2000). 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)
- K071519: Hemcon Chitoflex-Surgical Dressing, Hemcon, Inc. (2007) Summary page 5.
- K072474: Quikclot EX, Z-Medica Corporation (2007) Summary page 5.

## Indications for use
TRAUMASTAT'M Hemostatic Wound Dressing is intended for external temporary use to control moderate to severe bleeding. TRAUMASTAT TM Hemostatic Wound Dressing is intended for external temporary use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Source page: https://510kreport.com/device/K080648
Methodology: https://510kreport.com/methodology