# K200720: D-Stat Radial Topical Hemostat

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, LLC
- Decided: Jun 26, 2020 after 99 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). 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)
- K050133: D-Stat Radial Hemostatic Band, Vascular Solutions, Inc. (2005) Summary page 5.

## Indications for use
The D-Stat Radial Topical Hemostat 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/K200720
Methodology: https://510kreport.com/methodology