# K091795: Medtrade Products Celox Trauma Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Nov 20, 2009 after 156 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: 7 generations back to K002550 (2000). 18 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080097: Medtrade Products Celox Hemostatic Granules on Sheet, Medtrade Products, Ltd. (2008) Summary page 6.
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266, Hem Con Medical Technologies, Inc. (2009) Summary page 6.

## Most influential descendants
- 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
- K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) (2015), 2 descendants of its own
- K232216: Hemoblock_S (Prescription); Hemoblock_S (OTC) (2024), 0 descendants of its own
- K222909: Axiostat Gauze (2023), 0 descendants of its own
- K172155: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing (2018), 0 descendants of its own

## Indications for use
CELOX Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions. CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

Source page: https://510kreport.com/device/K091795
Methodology: https://510kreport.com/methodology