# K043050: Hemcon Bandage and Hemcon Bandage Otc

- Pathway: 510(k) (Abbreviated)
- Applicant: Hemcon, Inc.
- Decided: Jun 3, 2005 after 211 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: 3 generations back to K972914 (1997). 5 ancestors in all.
55 later devices descend from it; 6 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023298: Hemcon Bandage, Hemcon, Inc. (2002) Summary page 6.
- K030946: Hemcon Bandage Otc; Hemcon Cath/Aid, Hemcon, Inc. (2003) Summary page 6.

## Most influential descendants
- K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc (2008), 35 descendants of its own
- K071519: Hemcon Chitoflex-Surgical Dressing (2007), 22 descendants of its own
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266 (2009), 20 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own
- K092357: Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging Strip, 1/2 (2009), 10 descendants of its own

## Indications for use
The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding. 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.

Source page: https://510kreport.com/device/K043050
Methodology: https://510kreport.com/methodology