# K200167: QuikClot Control+

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medica, LLC
- Decided: Apr 23, 2020 after 91 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: 1 generation back to DEN160012 (2017). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160012: D2 Dressing, Z-Medica, LLC (2017) Summary page 4.

## Most influential descendants
- K220971: QuikClot Control+ Hemostatic Dressing (2022), 1 descendant of its own
- K243553: QuikClot Control+ Hemostatic Device (2025), 0 descendants of its own
- K213198: Ax-Surgi Surgical Hemostat (2023), 0 descendants of its own

## Indications for use
QuickClot 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.

Source page: https://510kreport.com/device/K200167
Methodology: https://510kreport.com/methodology