# K040510: Vascular Solutions D-Stat Dry 3X3 Hemostatic Pad

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Mar 17, 2004 after 19 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage: named in the summary without a submission number
- (no number) On Site Gas Systems, Inc., QuikClot: named in the summary without a submission number
- (no number) Marine Polymer Technologies, Inc. RDH Bandage: named in the summary without a submission number

## Most influential descendants
- K072117: Thrombix Patch Thrombin Hemostasis Patch (2007), 2 descendants of its own
- K083190: D-Stat Dry Wrap Hemostatic Bandage, Model: 3015 (2008), 1 descendant of its own
- K102212: D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver (2011), 0 descendants of its own
- K053054: Thrombix 3X3 Hemostatic Pad (2005), 0 descendants of its own

## Indications for use
The D-Stat Dry 3X3 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/K040510
Methodology: https://510kreport.com/methodology