# K202751: TandemHeart Pump and Escort Controller

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Mar 26, 2021 after 186 days
- Product code: QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 81 FR 7451, Feb. 12, 2016: named in the summary without a submission number

## Most influential descendants
- K230364: VitalFlow™ Console (2023), 1 descendant of its own
- K250199: VitalFlow Console (2025), 0 descendants of its own
- K223898: VitalFlowTM Centrifugal Pump (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K202751
Methodology: https://510kreport.com/methodology