# K192671: Hemostatic Xerogel Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Solaplus Biotech Co., Ltd.
- Decided: Aug 28, 2020 after 337 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 K002550 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153582: Prometheus ChitoGauze XR PRO, Hem Con Medical Technologies, Inc. (2016) Summary page 6.

## Indications for use
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Source page: https://510kreport.com/device/K192671
Methodology: https://510kreport.com/methodology