# K220971: QuikClot Control+ Hemostatic Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medica, LLC
- Decided: Dec 14, 2022 after 254 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: 2 generations back to DEN160012 (2017). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200167: QuikClot Control+, Z-Medica, LLC (2020) Summary page 4.

## Most influential descendants
- K243553: QuikClot Control+ Hemostatic Device (2025), 0 descendants of its own

## Indications for use
QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.

Source page: https://510kreport.com/device/K220971
Methodology: https://510kreport.com/methodology