510(k) · Cleared
ClearedQuikClot Control+ Hemostatic 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
Cleared on Dec 14, 2022 as substantially equivalent to K200167 (Z-Medica, LLC, 2020) after a 254-day review. Its family tree reaches back 2 generations to 2017. 1 later device descends from it.
- Decided
- Dec 14, 2022
- Review
- 254 days
- Class
- Class II
- Product code
- POD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160012 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN160012 D2 DressingZ-Medica, LLC · 2017
- 1 generation backK200167 QuikClot Control+Z-Medica, LLC · 2020
- This deviceK220971 QuikClot Control+ Hemostatic DressingZ-Medica, LLC · 2022
- Descendant · cites it directly · 0 of its ownK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
Most influential descendants
Showing 1 of 1 · See all- K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160012 | D2 Dressing | Z-Medica, LLC | 2017 | — |
| −1 | K200167 | QuikClot Control+ | Z-Medica, LLC | 2020 | — |
| 0 (this device) | K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | 2022 | — |
| +1 | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200167 | QuikClot Control+Summary page 4…hemostatic gauze for temporary internal use. (Class II, POD, 21 CFR 878.4454) 3. Predicate Device QuikClot Control+® Hemostatic Dressing (K200167) 4. Device Description and Mechanism of Action Device Description QuikClot Control+® Hemostatic Dressing is a prescription… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243553 | QuikClot Control+ Hemostatic Device | 2025 | 0 |
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243553 (Teleflex Medical, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200167.
How does its category compare?
All POD devicesPOD Temporary, Internal Use Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220971: QuikClot Control+ Hemostatic Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220971
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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