510(k) · Cleared
ClearedTandemHeart Pump and Escort Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Cleared on Mar 26, 2021 after a 186-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 26, 2021
- Review
- 186 days
- Class
- Class II
- Product code
- QNR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK202751 TandemHeart Pump and Escort ControllerCardiacassist, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK230364 VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK250199 VitalFlow ConsoleMedtronic, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK223898 VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023
Most influential descendants
Showing 3 of 3 · See all- K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023 · cites it directly1descendant
- K250199VitalFlow ConsoleMedtronic, Inc. · 2025 · 2 generations on0descendants
- K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | 2021 | — |
| +1 | K230364 | VitalFlow™ Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023 | 1 |
| +2 | K250199 | VitalFlow Console | Medtronic, Inc. | 2025 | 1 |
| +1 | K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 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.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K230364 (Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.), 2023) has gone furthest, with 1 descendant of its own.
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. 2021, 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 TandemHeart System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient’s blood in 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202751: TandemHeart Pump and Escort Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202751
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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