510(k) · Cleared
ClearedQuikClot Control+ Hemostatic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · POD Temporary, Internal Use Hemostatic
Cleared on Mar 18, 2025 as substantially equivalent to K220971 (Z-Medica, LLC, 2022) and 1 other predicate after a 120-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Mar 18, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- POD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K013225 (2001). 9 ancestors in all, the oldest K002550 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK013225 Instaclot for Otc Use, Traumasstat for Prescription UseMedafor, Inc. · 2001
- 4 generations backK061722 Bloxx Rapid Clotting AgentCrosslink-D, Inc. · 2006
- 3 generations backK082703 MRDH BandageMarine Polymer Technologies, Inc. · 2008
- 2 generations backK103641 GuardacareHem Con Medical Technologies, Inc. · 2011
- 1 generation backK140757 D2 Hemostantic DressingZ-Medica, LLC · 2014
- This deviceK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013225 | Instaclot for Otc Use, Traumasstat for Prescription Use | Medafor, Inc. | 2001 | — |
| −4 | K061722 | Bloxx Rapid Clotting Agent | Crosslink-D, Inc. | 2006 | — |
| −3 | K082703 | MRDH Bandage | Marine Polymer Technologies, Inc. | 2008 | — |
| −2 | K103641 | Guardacare | Hem Con Medical Technologies, Inc. | 2011 | — |
| −1 | K140757 | D2 Hemostantic Dressing | Z-Medica, LLC | 2014 | — |
| 0 (this device) | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 K220971 QuikClot Control+ Hemostatic Dressingscore 7.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K220971 | QuikClot Control+ Hemostatic DressingSummary page 5…CFR 878.4454) Regulatory Class: II Product Code: POD III. Predicate Device Primary Predicate: QuikClot Control+TM Hemostatic Dressing (K220971) Secondary Predicate: D2 Hemostatic Dressing (K140757) IV. Device Description and Mechanism of Action Device De… | 2022 |
| * | K140757 | D2 Hemostantic DressingSummary page 5…Code: POD III. Predicate Device Primary Predicate: QuikClot Control+TM Hemostatic Dressing (K220971) Secondary Predicate: D2 Hemostatic Dressing (K140757) IV. Device Description and Mechanism of Action Device Description QuikClot Control+™ Hemostatic Device consist… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All POD devicesPOD Temporary, Internal Use Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243553: QuikClot Control+ Hemostatic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243553
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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