510(k) · Cleared
ClearedQuikClot Control+
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
Cleared on Apr 23, 2020 as substantially equivalent to DEN160012 (Z-Medica, LLC, 2017) after a 91-day review. Its family tree reaches back 1 generation to 2017. 3 later devices descend from it.
- Decided
- Apr 23, 2020
- Review
- 91 days
- Class
- Class II
- Product code
- POD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160012 (2017). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN160012 D2 DressingZ-Medica, LLC · 2017
- This deviceK200167 QuikClot Control+Z-Medica, LLC · 2020
- Descendant · cites it directly · 1 of its ownK220971 QuikClot Control+ Hemostatic DressingZ-Medica, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
- Descendant · cites it directly · 0 of its ownK213198 Ax-Surgi Surgical HemostatAdvamedica, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160012 | D2 Dressing | Z-Medica, LLC | 2017 | — |
| 0 (this device) | K200167 | QuikClot Control+ | Z-Medica, LLC | 2020 | — |
| +1 | K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | 2022 | — |
| +2 | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
| +1 | K213198 | Ax-Surgi Surgical Hemostat | Advamedica, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160012 | D2 DressingSummary page 4…Regulation Number: 21 CFR §878.4454 Product Code: POD Predicate Device: Z-Medica, LLC QuikClot Control+® Hemostatic Dressing (DEN160012, cleared as D2 Dressing) Reference Device: Z-Medica, LLC QuikClot Control+® Hemostatic D… | 2017 |
| † | K140757 | D2 Hemostantic Dressing | 2014 |
What descends from it? (3)
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?
How does its category compare?
All POD devicesPOD Temporary, Internal Use Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200167: QuikClot Control+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200167
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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