# K072328: Medtrade Products Celox Solbag, Anti - Coagulant

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Dec 21, 2007 after 123 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K051955: Quickclot Acs - Accelerated Clotting Sponge, Z-Medica Corporation (2005) Summary page 6.

## Indications for use
MedTrade Products CELOX Topical Hemostatic Granules are intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. MedTrade Products CELOX Topical Hemostatic Granules are intended to be available Over The Counter for the following indication. MedTrade Products CELOX Topical Hemostatic Granules OTC are indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

Source page: https://510kreport.com/device/K072328
Methodology: https://510kreport.com/methodology