# K071519: Hemcon Chitoflex-Surgical Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hemcon, Inc.
- Decided: Aug 6, 2007 after 63 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 K972914 (1997). 6 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 29 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 5.

## Most influential descendants
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own
- K190528: MariGen Wound Extra (2019), 3 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

## Indications for use
HemCon ChitoFlexTM Surgical is intended for use as a topical 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.

Source page: https://510kreport.com/device/K071519
Methodology: https://510kreport.com/methodology