# K050133: D-Stat Radial Hemostatic Band

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 18, 2005 after 28 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: 4 generations back to K896068 (1990). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage, Vascular Solutions, Inc. (2003) Summary page 5.

## Most influential descendants
- K200720: D-Stat Radial Topical Hemostat (2020), 0 descendants of its own
- K092612: D-Stat Rad-Band,  Rad-Band, Models 3501, 3505 (2009), 0 descendants of its own

## Indications for use
The D-Stat Radial Hemostatic Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

Source page: https://510kreport.com/device/K050133
Methodology: https://510kreport.com/methodology