# K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Sep 17, 2003 after 184 days
- Product code: QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896068 (1990). 4 ancestors in all.
44 later devices descend from it; 8 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012293: Vascular Solutions Duett Flowable Hemostat, Vascular Solutions, Inc. (2002)
- K982818: Hospal Tipstop, Gambro Healthcare (1998) Summary page 6.
- (no number) TZ Medical Inc., EZ Band: named in the summary without a submission number

## Most influential descendants
- K050511: Thrombigel Thrombin/Gelatin Foam Hemostat (2005), 25 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own
- K053300: Syvekexcel (2006), 14 descendants of its own
- K061219: D-Stat Dry Hemostatic Bandage (2006), 13 descendants of its own

## Recalls of this device
- Sep 15, 2005 · Not classified · Z-0003-06: package sealing defect - product may not be sterile
- Sep 9, 2005 · Not classified · Z-0142-06: A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which a
- Sep 9, 2005 · Not classified · Z-0143-06: A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which a

## Indications for use
The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.

Source page: https://510kreport.com/device/K030836
Methodology: https://510kreport.com/methodology