# K211570: Zeolite Hemostatic Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Zeo-Innov Life Technology Co., Ltd.
- Decided: Feb 10, 2022 after 265 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 K002550 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072474: Quikclot EX, Z-Medica Corporation (2007) Summary page 6.

## Most influential descendants
- K223495: Zeolite Hemostatic Cotton (2023), 0 descendants of its own

## Indications for use
Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Source page: https://510kreport.com/device/K211570
Methodology: https://510kreport.com/methodology