510(k) · Cleared
Recalled · Class I · 2023LifeSPARC Pump, LifeSPARC Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Jul 9, 2019 as substantially equivalent to K110493 (Cardiacassist, Inc., 2011) after a 195-day review. Its family tree reaches back 7 generations to 1985. 2 of the 14 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Jul 9, 2019
- Review
- 195 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 3 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K852698 (1985). 12 ancestors in all, the oldest K780953 (1978). 1 later device descends from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 6 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 5 generations backK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- 4 generations backK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
- 3 generations backK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
- 2 generations backK083340 Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary…Levitronix, LLC · 2008 · Recalled
- 1 generation backK110493 Tandemheart PumpCardiacassist, Inc. · 2011 · Recalled
- This deviceK183623 LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK232132 LifeSPARC SystemCardiacassist, Inc. · 2023
Class I recalls in this family
- K020271 Levitronix Centrimag Extracorporeal Blood…2 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K232132LifeSPARC SystemCardiacassist, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −6 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −5 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| −4 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
| −3 | K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | 2008 | — |
| −2 | K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console | Levitronix, LLC | 2008 | 1 |
| −1 | K110493 | Tandemheart Pump | Cardiacassist, Inc. | 2011 | 8 |
| 0 (this device) | K183623 | LifeSPARC Pump, LifeSPARC Controller | Cardiacassist, Inc. | 2019 | — |
| +1 | K232132 | LifeSPARC System | Cardiacassist, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
2 devices in this family have a Class I recall. 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 KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 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 |
|---|---|---|---|
| * | K110493 | Tandemheart PumpSummary page 4…Control, pump speed, cardiopulmonary bypass (21 CFR 870.4360 / Product Code DWA) Predicate Device: TandemHeart System (K110493) Reference Devices: TandemHeart Pump (K991783) Escort Controller (K061369) Device Description The LifeSPARC Pump is a sterile, si… | 2011 |
| † | K991783 | AB-180 XC System, Model AB-180XC | 2000 |
| † | K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232132 | LifeSPARC System | 2023 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2023 | Class II | Z-2465-2023 | Under Investigation by firm | 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 | Software design | 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 initiated July 21, 2022. During the Critical… |
| Jul 21, 2022 | Class I | Z-1763-2022 | Under Investigation by firm | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232132 (Cardiacassist, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, 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 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183623: LifeSPARC Pump, LifeSPARC Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183623
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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