# K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: May 15, 2008 after 52 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 K896068 (1990). 42 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043050: Hemcon Bandage and Hemcon Bandage Otc, Hemcon, Inc. (2005) Summary page 6.
- K071519: Hemcon Chitoflex-Surgical Dressing, Hemcon, Inc. (2007) Summary page 6.
- K072900: Excelarrest  Foam, Hemostasis, LLC (2007) Summary page 6.
- K021062: Chito-Seal, Abbott Vascular, Inc. (2002) Summary page 6.
- K032986: Clo-Surplusp.a.D., Scion Cardio-Vascular, Inc. (2004) Summary page 6.
- K033666: Hemaderm, Medafor, Inc. (2003) Summary page 6.

## Most influential descendants
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own
- K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO (2015), 3 descendants of its own
- K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet (2010), 2 descendants of its own
- K182811: gel-e Flex+ (2019), 1 descendant of its own
- K120782: Interventional Hemostatic Bandage (2013), 1 descendant of its own

## Indications for use
HemCon ChitoFlex TM-Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. The HemCon Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon Bandage also controls bleeding in patients following hemodialysis. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

Source page: https://510kreport.com/device/K080818
Methodology: https://510kreport.com/methodology