# K220566: Vascette HP (hemostatic pad)

- Pathway: 510(k) (Traditional)
- Applicant: Koag, LLC
- Decided: Jul 29, 2022 after 151 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: 6 generations back to K914575 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090100: Softseal-STF, Chitogen, Inc. (2009) Summary page 4.

## Indications for use
Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.

Source page: https://510kreport.com/device/K220566
Methodology: https://510kreport.com/methodology