# K240713: Traumagel®

- Pathway: 510(k) (Traditional)
- Applicant: Cresilon, Inc.
- Decided: Aug 14, 2024 after 152 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: 5 generations back to K002550 (2000). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113560: Celox Gauze Pro, Medtrade Products, Ltd. (2012) Summary page 5.
- K093593: Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro, Medtrade Products Limited (2010) Summary page 7.

## Most influential descendants
- K250319: Mfuse (MS001) (2025), 0 descendants of its own
- K253609: TRAUMAGEL® 2.0 Hemostatic Gel (2025), 0 descendants of its own

## Indications for use
TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.

Source page: https://510kreport.com/device/K240713
Methodology: https://510kreport.com/methodology