De Novo · Granted
GrantedD2 Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Medica, LLC · POD Temporary, Internal Use Hemostatic
Granted on Jun 30, 2017 as a new device type through De Novo after a 471-day review. 5 later devices descend from it.
- Decided
- Jun 30, 2017
- Review
- 471 days
- Class
- Class II
- Product code
- POD
- Recalls
- None
5 later devices descend from it, 2 citing it directly.
- This deviceDEN160012 D2 DressingZ-Medica, LLC · 2017
- Descendant · cites it directly · 3 of its ownK200167 QuikClot Control+Z-Medica, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK220971 QuikClot Control+ Hemostatic DressingZ-Medica, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
- Descendant · 2 generations on · 0 of its ownK213198 Ax-Surgi Surgical HemostatAdvamedica, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK183190 NuStatBeeken Biomedical, LLC · 2019 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K200167QuikClot Control+Z-Medica, LLC · 2020 · cites it directly3descendants
- K220971QuikClot Control+ Hemostatic DressingZ-Medica, LLC · 2022 · 2 generations on1descendant
- K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025 · 3 generations on0descendants
- K213198Ax-Surgi Surgical HemostatAdvamedica, Inc. · 2023 · 2 generations on0descendants
- K183190NuStatBeeken Biomedical, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160012 | D2 Dressing | Z-Medica, LLC | 2017 | — |
| +1 | K200167 | QuikClot Control+ | Z-Medica, LLC | 2020 | — |
| +2 | K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | 2022 | — |
| +3 | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
| +2 | K213198 | Ax-Surgi Surgical Hemostat | Advamedica, Inc. | 2023 | — |
| +1 | K183190 | NuStat | Beeken Biomedical, LLC | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in POD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new POD device
- #1 K243553 QuikClot Control+ Hemostatic Devicescore 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200167 (Z-Medica, LLC, 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All POD devicesPOD Temporary, Internal Use Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · POD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POD
Too few POD 510(k)s in any year since 2007 to give a median.
Recalls per year · POD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POD
1in 2025
MAUDE reports naming product code POD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160012 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN160012: D2 Dressing.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN160012
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026