# K061219: D-Stat Dry Hemostatic Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Oct 6, 2006 after 158 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: 7 generations back to K953781 (1995). 26 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 40 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 6.
- K053300: Syvekexcel, Marine Polymer Technologies, Inc. (2006) Summary page 6.

## Most influential descendants
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own
- K072890: Stasilon FR (2007), 5 descendants of its own
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own
- K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet (2010), 2 descendants of its own

## Indications for use
The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.

Source page: https://510kreport.com/device/K061219
Methodology: https://510kreport.com/methodology