510(k) · Cleared
Recalled · Class II · 2025VitalFlow™ Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Cleared on Aug 25, 2023 as substantially equivalent to K202751 (Cardiacassist, Inc., 2021) after a 196-day review. Its family tree reaches back 1 generation to 2021. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 25, 2023
- Review
- 196 days
- Class
- Class II
- Product code
- QNR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K202751 (2021). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK202751 TandemHeart Pump and Escort ControllerCardiacassist, Inc. · 2021
- This deviceK230364 VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023
- Descendant · cites it directly · 0 of its ownK250199 VitalFlow ConsoleMedtronic, Inc. · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K250199VitalFlow ConsoleMedtronic, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | 2021 | — |
| 0 (this device) | K230364 | VitalFlow™ Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023 | — |
| +1 | K250199 | VitalFlow Console | Medtronic, Inc. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 QNR? 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 QNR device
- #1 K234118 CentriMag™ Acute Circulatory Support Systemscore 9.1 · 9 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 |
|---|---|---|---|
| * | K202751 | TandemHeart Pump and Escort ControllerSummary page 4…21 CFR 870.4100 Product Code: QNR Predicate: TandemHeart Escort Controller (K202751) Reference Devices: Medtronic Bio-Console 560 (K131964) and Medtronic… | 2021 |
| † | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | 2013 |
| † | K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance… | 2019 |
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 |
|---|---|---|---|
| K250199 | VitalFlow Console | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2025 | Class II | Z-0509-2026 | Software in the Use Environment | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QNR devicesQNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QNR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNR
Too few QNR 510(k)s in any year since 2007 to give a median.
Recalls per year · QNR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QNR
187in 2025
MAUDE reports naming product code QNR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 135 |
| 2025 | 1 | — | 1 | 187 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VitalFlow™ Console controls the speed of the VitalFlow™ Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230364: VitalFlow™ Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230364
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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