# K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc

- Pathway: 510(k) (Traditional)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: Aug 6, 2008 after 337 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 6 (0 Class I)
- 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.
35 later devices descend from it; 4 cite it directly.
0 of 42 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.

## Most influential descendants
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266 (2009), 20 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
- K102546: Chitogauze (2010), 9 descendants of its own
- K091795: Medtrade Products Celox Trauma Gauze (2009), 7 descendants of its own
- K120958: Posisep and Posisep X Hemostat Dressings (2012), 6 descendants of its own

## Recalls of this device
- Apr 3, 2012 · Not classified · Z-1493-2012: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one seg
- May 25, 2011 · Not classified · Z-2789-2011: Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
- Apr 15, 2011 · Not classified · Z-2404-2011: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one seg
- Mar 31, 2011 · Not classified · Z-2216-2011: Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and 
- Mar 31, 2011 · Not classified · Z-2243-2011: Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.
- Mar 24, 2011 · Not classified · Z-2190-2011: When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.

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

Source page: https://510kreport.com/device/K072486
Methodology: https://510kreport.com/methodology