# K172155: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Statguard, LLC
- Decided: Apr 12, 2018 after 269 days
- Product code: QSY (Hemostatic Wound Dressing Without 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: 10 generations back to K953781 (1995). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use), Benq Materials Corporation (2015) Summary page 5.
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266, Hem Con Medical Technologies, Inc. (2009) Summary page 5.
- K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet, Medtrade Products, Ltd. (2010) Summary page 5.

## Indications for use
The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites. The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.

Source page: https://510kreport.com/device/K172155
Methodology: https://510kreport.com/methodology