# K121485: Guardiva Antimicrobial Haemstatic IV Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hemcon Medical Technologies Europe, Ltd.
- Decided: Aug 21, 2012 after 95 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: 5 generations back to K953781 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093729: Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva Antimicrobial Haemostatic IV Dressing, 1 I, Hemcon Medical Technologies Europe, Ltd. (2010) Summary page 5.

## Indications for use
The HemCon GuardIVa® Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.

Source page: https://510kreport.com/device/K121485
Methodology: https://510kreport.com/methodology