# K202830: Axiostat Patch

- Pathway: 510(k) (Traditional)
- Applicant: Advamedica, Inc.
- Decided: Apr 15, 2021 after 202 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: 8 generations back to K896068 (1990). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO, Hem Con Medical Technologies, Inc. (2015) Summary page 5.
- K102944: Coreleader Hemo-Pad Model Cpii 02030, Coreleader Biotech Co., Ltd. (2011) Summary page 5.

## Indications for use
Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

Source page: https://510kreport.com/device/K202830
Methodology: https://510kreport.com/methodology