510(k) · Cleared
ClearedModification to Cardiovention Powerbase Console, Model PCB-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovention, Inc. · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Feb 26, 2003 as substantially equivalent to K021694 (Cardiovention, Inc., 2003) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Feb 26, 2003
- Review
- 42 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991864 (2000). 5 ancestors in all, the oldest K936091 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK991864 Rotaflow Centrifugal Pump SystemJostra Medizintechnik AG · 2000 · Recalled
- 2 generations backK011838 Centrifugal PumpStockert Instrumente GmbH · 2002 · Recalled
- 1 generation backK021694 Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc. · 2003
- This deviceK030141 Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991864 | Rotaflow Centrifugal Pump System | Jostra Medizintechnik AG | 2000 | 2 |
| −2 | K011838 | Centrifugal Pump | Stockert Instrumente GmbH | 2002 | 4 |
| −1 | K021694 | Cardiovention Powerbase Console, Model PBC-100 | Cardiovention, Inc. | 2003 | — |
| 0 (this device) | K030141 | Modification to Cardiovention Powerbase Console, Model PCB-100 | Cardiovention, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 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 DTQ? 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 DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 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? (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.
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 3 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, 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 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CardioVention PowerBaseTMConsole is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six Iiterdminute and lasting for up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030141: Modification to Cardiovention Powerbase Console, Model PCB-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030141
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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