510(k) · Cleared
ClearedpREBOA-PRO Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prytime Medical Devices, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Sep 5, 2025 as substantially equivalent to K200459 (Prytime Medical Devices, Inc., 2020) after a 269-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Sep 5, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003495 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 7 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 6 generations backK122917 Coda Balloon CatheterCook, Inc. · 2013
- 5 generations backK150970 Coda LP Balloon CatheterCook Incorporated · 2015
- 4 generations backK151821 ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
- 3 generations backK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- 2 generations backK172790 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- 1 generation backK200459 pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2020
- This deviceK243795 pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −7 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −6 | K122917 | Coda Balloon Catheter | Cook, Inc. | 2013 | — |
| −5 | K150970 | Coda LP Balloon Catheter | Cook Incorporated | 2015 | — |
| −4 | K151821 | ER-REBOA Catheter | Pryor Medical Devices, Inc. | 2015 | — |
| −3 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| −2 | K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| −1 | K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020 | — |
| 0 (this device) | K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2014 | 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 MJN? 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 MJN device
- #1 K251358 Bridge Plus Occlusion Balloon (590-002)score 10.5 · 4 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 |
|---|---|---|---|
| * | K200459 | pREBOA-PRO CatheterSummary page 5…t Code: MJN, DQY, DQO Submission Type: Traditional 510(k) Predicate device: pREBOA-PRO Catheter cleared under 510(k) number K200459. Page 2 of 3 Device… | 2020 |
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 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The pREBOA-PRO Catheter is intended for temporary partial or complete occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243795: pREBOA-PRO Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243795
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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