# K050769: Quikclot Brand Hemostatic Agent - Advanced Beaded Formulation - 100G - 1.9MM - 2.4MM., Model 100172

- Pathway: 510(k) (Special)
- Applicant: Z-Medica Corporation
- Decided: Apr 14, 2005 after 20 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
QuikClot® Brand Hemostatic Agent 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/K050769
Methodology: https://510kreport.com/methodology