510(k) · Cleared
ClearedER-REBOA Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pryor Medical Devices, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 23, 2015 as substantially equivalent to K032869 (Cook, Inc., 2003) and 2 other predicates after a 109-day review. Its family tree reaches back 4 generations to 2001. 9 later devices descend from it.
- Decided
- Oct 23, 2015
- Review
- 109 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K003495 (2001). 6 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 3 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 2 generations backK122917 Coda Balloon CatheterCook, Inc. · 2013
- 1 generation backK150970 Coda LP Balloon CatheterCook Incorporated · 2015
- This deviceK151821 ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK172790 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK210358 Neurescue deviceNeurescue Aps · 2021
- Descendant · 3 generations on · 1 of its ownK200459 pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK243795 pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · cites it directly8descendants
- K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 2 generations on4descendants
- K210358Neurescue deviceNeurescue Aps · 2021 · 2 generations on1descendant
- K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2020 · 3 generations on1descendant
- K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −3 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −2 | K122917 | Coda Balloon Catheter | Cook, Inc. | 2013 | — |
| −1 | K150970 | Coda LP Balloon Catheter | Cook Incorporated | 2015 | — |
| 0 (this device) | K151821 | ER-REBOA Catheter | Pryor Medical Devices, Inc. | 2015 | — |
| +1 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +2 | K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +2 | K210358 | Neurescue device | Neurescue Aps | 2021 | — |
| +3 | K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K032869 | Cook Coda Balloon CatheterSummary page 4…Predicate Devices 5.1 The ER-REBOA™ Catheter is claimed to be substantially equivalent to the following devices: 5.1.1 Cook Coda Balloon Catheter (K032869), manufactured by Cook Incorporated 5.1.2 Coda LP Balloon Catheter (K150970), manufactured by Cook… | 2003 |
| * | K150970 | Coda LP Balloon CatheterSummary page 4…the following devices: 5.1.1 Cook Coda Balloon Catheter (K032869), manufactured by Cook Incorporated 5.1.2 Coda LP Balloon Catheter (K150970), manufactured by Cook Incorporated 5.1.3 Cook Pressure Monitoring Catheter (K002254), manufactured… | 2015 |
| * | K002254 | Cook Pressure Monitoring CatheterSummary page 4…Incorporated 5.1.2 Coda LP Balloon Catheter (K150970), manufactured by Cook Incorporated 5.1.3 Cook Pressure Monitoring Catheter (K002254), manufactured by Cook Incorporated 6 Device Description 6.1 The ER-REBOATM Catheter is a large vessel occ… | 2001 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170411 | ER-REBOA Catheter | 2017 | 8 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K170411 (Prytime Medical Devices, Inc., 2017) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K032869.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The ER-REBOA Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151821: ER-REBOA Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151821
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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