# K072474: Quikclot EX

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medica Corporation
- Decided: Oct 16, 2007 after 42 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002550 (2000). 8 ancestors in all.
36 later devices descend from it; 8 cite it directly.
0 of 45 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.
- K070010: Quikclot Sport and Quikclot Sport Silver, Z-Medica Corporation (2007) Summary page 5.
- K821150: NU-Gauze Sponge, Johnson & Johnson Professionals, Inc. (1982) Summary page 5.

## Most influential descendants
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266 (2009), 20 descendants of its own
- K092357: Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging Strip, 1/2 (2009), 10 descendants of its own
- K102546: Chitogauze (2010), 9 descendants of its own
- K091795: Medtrade Products Celox Trauma Gauze (2009), 7 descendants of its own
- K133121: Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active, 4INX4IN,Chito-Sam Active, 3INX6FT (2014), 5 descendants of its own

## Recalls of this device
- Sep 22, 2021 · Class II · Z-0211-2022: Lack of Packaging seal integrity may result in a sterile barrier breach.

## Indications for use
QuikClot® eXTM is intended for temporary external use to control traumatic bleeding. QuikClot® eXTM is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Source page: https://510kreport.com/device/K072474
Methodology: https://510kreport.com/methodology