510(k) · Cleared
ClearedCoda LP Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DQY Catheter, Percutaneous
Cleared on May 12, 2015 as substantially equivalent to K032869 (Cook, Inc., 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 2001. 10 later devices descend from it.
- Decided
- May 12, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003495 (2001). 4 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 2 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 1 generation backK122917 Coda Balloon CatheterCook, Inc. · 2013
- This deviceK150970 Coda LP Balloon CatheterCook Incorporated · 2015
- Descendant · cites it directly · 9 of its ownK151821 ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK172790 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK210358 Neurescue deviceNeurescue Aps · 2021
- Descendant · 4 generations on · 1 of its ownK200459 pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151821ER-REBOA CatheterPryor Medical Devices, Inc. · 2015 · cites it directly9descendants
- K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 2 generations on8descendants
- K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 3 generations on4descendants
- K210358Neurescue deviceNeurescue Aps · 2021 · 3 generations on1descendant
- K200459pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −2 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −1 | K122917 | Coda Balloon Catheter | Cook, Inc. | 2013 | — |
| 0 (this device) | K150970 | Coda LP Balloon Catheter | Cook Incorporated | 2015 | — |
| +1 | K151821 | ER-REBOA Catheter | Pryor Medical Devices, Inc. | 2015 | — |
| +2 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +3 | K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +3 | K210358 | Neurescue device | Neurescue Aps | 2021 | — |
| +4 | K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K032869 | Cook Coda Balloon CatheterSummary page 4…ular prostheses. Predicate Devices: The device subject of this submission is substantially equivalent to the predicate devices, cleared for market under 510(k) numbers K032869 on November 19, 2003 and K122917 on June 28, 2013. Comparison to Predicate Devices: It has been demonstrated that the Coda LP Ba… | 2003 |
| * | K122917 | Coda Balloon CatheterSummary page 4…es: The device subject of this submission is substantially equivalent to the predicate devices, cleared for market under 510(k) numbers K032869 on November 19, 2003 and K122917 on June 28, 2013. Comparison to Predicate Devices: It has been demonstrated that the Coda LP Balloon Catheters are comparable to… | 2013 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151821 | ER-REBOA Catheter | 2015 | 9 |
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 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151821 (Pryor Medical Devices, Inc., 2015) has gone furthest, with 9 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 Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150970: Coda LP Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150970
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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