# K102212: D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Apr 8, 2011 after 245 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: 8 generations back to K953781 (1995). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061219: D-Stat Dry Hemostatic Bandage, Vascular Solutions, Inc. (2006) Summary page 8.
- K073264: D-Stat Dry Clear Hemostatic Bandage, Model 3005, Vascular Solutions, Inc. (2007) Summary page 8.
- K083190: D-Stat Dry Wrap Hemostatic Bandage, Model: 3015, Vascular Solutions, Inc. (2008) Summary page 8.
- K072117: Thrombix Patch Thrombin Hemostasis Patch, Vascular Solutions, Inc. (2007) Summary page 8.
- K041268: Silversite or Calgitrol, Adri (2004) Summary page 8.
- K090254: Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat), Convatec, A Division of E.R. Squibb & Sons, LLC (2009) Summary page 8.

## Indications for use
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. D-Stat Dry Clear Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. 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. D-Stat Dry Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. 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. D-Stat Dry Wrap Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. 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. Thrombix Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

Source page: https://510kreport.com/device/K102212
Methodology: https://510kreport.com/methodology