# K243553: QuikClot Control+ Hemostatic Device

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Mar 18, 2025 after 120 days
- Product code: POD (Temporary, Internal Use Hemostatic)
- Device class: 2
- Regulation: 21 CFR 878.4454
- 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 K013225 (2001). 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)
- K220971: QuikClot Control+ Hemostatic Dressing, Z-Medica, LLC (2022) Summary page 5.
- K140757: D2 Hemostantic Dressing, Z-Medica, LLC (2014) Summary page 5.

## Indications for use
QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

Source page: https://510kreport.com/device/K243553
Methodology: https://510kreport.com/methodology