510(k) · Cleared
ClearedLifeSPARC System
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 Jan 19, 2024 as substantially equivalent to K211830 (Cardiacassist, Inc., 2022) after a 58-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Jan 19, 2024
- Review
- 58 days
- Class
- Class II
- Product code
- QNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K211830 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backK211830 LifeSPARC SystemCardiacassist, Inc. · 2022
- This deviceK233736 LifeSPARC SystemCardiacassist, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K211830 | LifeSPARC System | Cardiacassist, Inc. | 2022 | — |
| 0 (this device) | K233736 | LifeSPARC System | Cardiacassist, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K211830 | LifeSPARC SystemSummary page 4…Control, pump speed, cardiopulmonary bypass (21 CFR 870.4360 / Product Code DWA) Primary Predicate Device: LifeSPARC System (K211830) Reference Device: LifeSPARC System (K232132) This is a bundled submission for the devices cleared under submissions K211830 an… | 2022 |
| † | K232132 | LifeSPARC System | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2024, 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?
Extracorporeal Membrane Oxygenation 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…
Read the full statement (165 words)
Extracorporeal Membrane Oxygenation
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 adults.
Cardiopulmonary Bypass
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233736: LifeSPARC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233736
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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