510(k) · Cleared
ClearedCardiovention Powerbase Console, Model PBC-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 Jan 8, 2003 as substantially equivalent to K936091 (Medtronic Bio-Medicus, Inc., 1994) and 2 other predicates after a 231-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jan 8, 2003
- Review
- 231 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K991864 (2000). 3 ancestors in all, the oldest K936091 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK991864 Rotaflow Centrifugal Pump SystemJostra Medizintechnik AG · 2000 · Recalled
- 1 generation backK011838 Centrifugal PumpStockert Instrumente GmbH · 2002 · Recalled
- This deviceK021694 Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK030141 Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K030141Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991864 | Rotaflow Centrifugal Pump System | Jostra Medizintechnik AG | 2000 | 2 |
| −1 | K011838 | Centrifugal Pump | Stockert Instrumente GmbH | 2002 | 4 |
| 0 (this device) | K021694 | Cardiovention Powerbase Console, Model PBC-100 | Cardiovention, Inc. | 2003 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | K936091 | Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerSummary page 1…Name: Bio-medicus Bio-Console Manufacturer: Medtronic Status: Post-enactment 51O(k) # K936091 Name: Stockert Centrifugal Pump Manufacturer: Stockert lnstrumente GmbH Status:… | 1994 |
| * | K011838 | Centrifugal Pump | 2002 |
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 1…RotaFlow Centrifugal Pump System Manufacturer: Jostra Medizintechnik AG Status: Post-enactment 510(k) # K991864 CardioVention, Inc. CONFIDENTIAL Page 29 CardioVention Pow… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030141 | Modification to Cardiovention Powerbase Console, Model PCB-100 | 2003 | 0 |
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 1.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K030141 (Cardiovention, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K936091.
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 literdminute and lasting for up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021694 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021694: Cardiovention Powerbase Console, Model PBC-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021694
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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