# K183623: LifeSPARC Pump, LifeSPARC Controller

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Jul 9, 2019 after 195 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K852698 (1985). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110493: Tandemheart Pump, Cardiacassist, Inc. (2011) Summary page 4.

## Most influential descendants
- K232132: LifeSPARC System (2023), 0 descendants of its own

## Recalls of this device
- Jun 30, 2023 · Class II · Z-2465-2023: Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
- Dec 5, 2022 · Class I · Z-0926-2023: A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initia
- Jul 21, 2022 · Class I · Z-1763-2022: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

## Indications for use
The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K183623
Methodology: https://510kreport.com/methodology