# K103641: Guardacare

- Pathway: 510(k) (Traditional)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: Jun 16, 2011 after 185 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 K013225 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082703: MRDH Bandage, Marine Polymer Technologies, Inc. (2008) Summary page 5.

## Most influential descendants
- K140757: D2 Hemostantic Dressing (2014), 1 descendant of its own
- K243553: QuikClot Control+ Hemostatic Device (2025), 0 descendants of its own

## Indications for use
HemCon GuardaCareT'XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Source page: https://510kreport.com/device/K103641
Methodology: https://510kreport.com/methodology