# K211830: LifeSPARC System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Nov 15, 2022 after 519 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) FDA Final Order, 81 FR 7451, Feb. 12, 2016: named in the summary without a submission number

## Most influential descendants
- K233736: LifeSPARC System (2024), 0 descendants of its own

## Indications for use
The LifeSPARC 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. These may include: • Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients • ECMO-assisted cardiopulmonary resuscitation in adult

Source page: https://510kreport.com/device/K211830
Methodology: https://510kreport.com/methodology