# K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO

- Pathway: 510(k) (Traditional)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: Nov 10, 2015 after 218 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: 7 generations back to K896068 (1990). 46 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing, Hem Con Medical Technologies, Inc. (2008) Summary page 10.
- K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc, Hem Con Medical Technologies, Inc. (2008) Summary page 10.
- K071519: Hemcon Chitoflex-Surgical Dressing, Hemcon, Inc. (2007) Summary page 10.
- K043050: Hemcon Bandage and Hemcon Bandage Otc, Hemcon, Inc. (2005) Summary page 10.
- K030946: Hemcon Bandage Otc; Hemcon Cath/Aid, Hemcon, Inc. (2003) Summary page 10.
- K023298: Hemcon Bandage, Hemcon, Inc. (2002) Summary page 10.
- K112961: Clo-Surplus P.a.D., Scion Cardio-Vascular, Inc. (2011) Summary page 10.
- K092552: Clo-Surplus P.a.D., Scion Cardio-Vascular, Inc. (2009) Summary page 10.
- K032986: Clo-Surplusp.a.D., Scion Cardio-Vascular, Inc. (2004) Summary page 10.

## Most influential descendants
- K182811: gel-e Flex+ (2019), 1 descendant of its own
- K202830: Axiostat Patch (2021), 0 descendants of its own
- K192667: gel-e Flex+ gel OTC (2019), 0 descendants of its own

## Indications for use
The HemCon® Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins The HemCon® Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins The HemCon® Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins HemCon® ChitoFlex® PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins The HemCon® Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms The HemCon® Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.

Source page: https://510kreport.com/device/K150916
Methodology: https://510kreport.com/methodology