# K151204: HEMO-Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Jul 31, 2015 after 87 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: 7 generations back to K896068 (1990). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing, Hem Con Medical Technologies, Inc. (2008) Summary page 5.
- K123387: Quikclot Hemostatic Dressing, Z-Medica, LLC (2013) Summary page 5.
- K113560: Celox Gauze Pro, Medtrade Products, Ltd. (2012) Summary page 5.

## Indications for use
CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

Source page: https://510kreport.com/device/K151204
Methodology: https://510kreport.com/methodology