# K153582: Prometheus ChitoGauze XR PRO

- Pathway: 510(k) (Traditional)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: May 25, 2016 after 162 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: 9 generations back to K002550 (2000). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266, Hem Con Medical Technologies, Inc. (2009) Summary page 5.
- K092357: Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging Strip, 1/2, Hem Con Medical Technologies, Inc. (2009) Summary page 5.
- K102546: Chitogauze, Hem Con Medical Technologies, Inc. (2010) Summary page 5.

## Most influential descendants
- K230589: Celox Rapid X-Ray Gauze (2023), 0 descendants of its own
- K192671: Hemostatic Xerogel Sponge (2020), 0 descendants of its own

## Indications for use
Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds

Source page: https://510kreport.com/device/K153582
Methodology: https://510kreport.com/methodology