# K181641: QuikClot Radial

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medica, LLC
- Decided: Dec 24, 2018 after 186 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: 10 generations back to K953781 (1995). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120782: Interventional Hemostatic Bandage, Z-Medica Corporation (2013) Summary page 6.

## Indications for use
QuikClot® Radial® is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in (a) patients on drug/induced anti-coagulation treatment and (b) patients not on drug/induced anti-coagulation treatment.

Source page: https://510kreport.com/device/K181641
Methodology: https://510kreport.com/methodology