# K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266

- Pathway: 510(k) (Traditional)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: Mar 31, 2009 after 85 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.
20 later devices descend from it; 7 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc, Hem Con Medical Technologies, Inc. (2008) Summary page 5.
- K072474: Quikclot EX, Z-Medica Corporation (2007) Summary page 5.

## Most influential descendants
- 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
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own

## Indications for use
ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds. ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

Source page: https://510kreport.com/device/K090026
Methodology: https://510kreport.com/methodology