# K080097: Medtrade Products Celox Hemostatic Granules on Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Jul 9, 2008 after 177 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: 3 generations back to K002550 (2000). 5 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061079: Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules, Medtrade Products, Ltd. (2006) Summary page 6.

## Most influential descendants
- K113560: Celox Gauze Pro (2012), 11 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
- K240713: Traumagel® (2024), 2 descendants of its own
- K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) (2015), 2 descendants of its own

## Indications for use
MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control moderate to severe bleeding MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Source page: https://510kreport.com/device/K080097
Methodology: https://510kreport.com/methodology