# K230589: Celox Rapid X-Ray Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Nov 17, 2023 after 260 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: 10 generations back to K002550 (2000). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110386: Celox Rapid Gauze, Medtrade Products, Ltd. (2011) Summary page 5.
- K153582: Prometheus ChitoGauze XR PRO, Hem Con Medical Technologies, Inc. (2016) Summary page 5.

## Indications for use
Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Source page: https://510kreport.com/device/K230589
Methodology: https://510kreport.com/methodology