# K110386: Celox Rapid Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: May 10, 2011 after 89 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: 4 generations back to K002550 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K230589: Celox Rapid X-Ray Gauze (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K110386
Methodology: https://510kreport.com/methodology