# DEN160012: D2 Dressing

- Pathway: De Novo (Direct)
- Applicant: Z-Medica, LLC
- Decided: Jun 30, 2017 after 471 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K200167: QuikClot Control+ (2020), 3 descendants of its own
- 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
- K183190: NuStat (2019), 0 descendants of its own

## Indications for use
D2 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/DEN160012
Methodology: https://510kreport.com/methodology