# K053054: Thrombix 3X3 Hemostatic Pad

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 23, 2005 after 23 days
- Product code: QSX (Hemostatic Wound Dressing With 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 K896068 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040510: Vascular Solutions D-Stat Dry 3X3 Hemostatic Pad, Vascular Solutions, Inc. (2004) Summary page 5.
- K050511: Thrombigel Thrombin/Gelatin Foam Hemostat, Vascular Solutions, Inc. (2005) Summary page 5.

## Indications for use
The Thrombix 3X3 pad is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

Source page: https://510kreport.com/device/K053054
Methodology: https://510kreport.com/methodology