510(k) · Decided
DecidedpreCARDIA Occlusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jun 30, 2023 as substantially equivalent to K210358 (Neurescue Aps, 2021) after a 422-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jun 30, 2023
- Review
- 422 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003495 (2001). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 6 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 5 generations backK122917 Coda Balloon CatheterCook, Inc. · 2013
- 4 generations backK150970 Coda LP Balloon CatheterCook Incorporated · 2015
- 3 generations backK151821 ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
- 2 generations backK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- 1 generation backK210358 Neurescue deviceNeurescue Aps · 2021
- This deviceK221294 preCARDIA Occlusion SystemAbiomed, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −6 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −5 | K122917 | Coda Balloon Catheter | Cook, Inc. | 2013 | — |
| −4 | K150970 | Coda LP Balloon Catheter | Cook Incorporated | 2015 | — |
| −3 | K151821 | ER-REBOA Catheter | Pryor Medical Devices, Inc. | 2015 | — |
| −2 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| −1 | K210358 | Neurescue device | Neurescue Aps | 2021 | — |
| 0 (this device) | K221294 | preCARDIA Occlusion System | Abiomed, Inc. | 2023 | — |
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 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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 |
|---|---|---|---|
| * | K210358 | Neurescue deviceSummary page 5…MJN, DQY, DQO Regulation Description: Vascular Clamp C. Predicate Device The predicate device is the NEURESCUE Device (K210358) manufactured by Neurescue Aps. The QXMedical Occlusion Balloon Catheter (K183679) and the CoAxia FloControl Catheter (K090… | 2021 |
| † | K183679 | Occlusion Balloon Catheter | 2019 |
| † | K090970 | Flocontrol , Model 1028 | 2009 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 11 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. 2023, 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 preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221294: preCARDIA Occlusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221294
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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