# K112215: Hemcon Hemostatic Gel

- Pathway: 510(k) (Traditional)
- Applicant: Hemcon Medical Technologies Europe, Ltd.
- Decided: Apr 12, 2012 after 254 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: 4 generations back to K953781 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072681: Bloodstop Hemostatic Gauze; IX Hemostatic Gauze, Lifescience Plus, Inc. (2007) Summary page 5.
- K010933: Seal-on Topical Hempstatic Powder Spray, Alltracel Pharma, Ltd. (2002) Summary page 5.

## Indications for use
HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds. HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.

Source page: https://510kreport.com/device/K112215
Methodology: https://510kreport.com/methodology