# K102944: Coreleader Hemo-Pad Model Cpii 02030

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Sep 7, 2011 after 338 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: 5 generations back to K914575 (1991). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032986: Clo-Surplusp.a.D., Scion Cardio-Vascular, Inc. (2004) Summary page 5.
- K021062: Chito-Seal, Abbott Vascular, Inc. (2002) Summary page 5.
- K030334: T-Scientific T-Pad, T-Scientific, Inc. (2003) Summary page 5.

## Most influential descendants
- K202830: Axiostat Patch (2021), 0 descendants of its own
- K161013: InnoSEAL Hemostatic Pad (2016), 0 descendants of its own

## Indications for use
Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins)

Source page: https://510kreport.com/device/K102944
Methodology: https://510kreport.com/methodology