510(k) · Cleared
Recalled · Class II · 2020Tandemheart Pump
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 Sep 20, 2011 as substantially equivalent to K991783 (Cardiacassist, Inc., 2000) and 2 other predicates after a 210-day review. Its family tree reaches back 6 generations to 1985. 2 of the 14 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 20, 2011
- Review
- 210 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 6 generations to K852698 (1985). 11 ancestors in all, the oldest K780953 (1978). 2 later devices descend from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 5 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 4 generations backK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- 3 generations backK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
- 2 generations backK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
- 1 generation backK083340 Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary…Levitronix, LLC · 2008 · Recalled
- This deviceK110493 Tandemheart PumpCardiacassist, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK183623 LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK232132 LifeSPARC SystemCardiacassist, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −5 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −4 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| −3 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
| −2 | K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | 2008 | — |
| −1 | K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console | Levitronix, LLC | 2008 | 1 |
| 0 (this device) | K110493 | Tandemheart Pump | Cardiacassist, Inc. | 2011 | — |
| +1 | K183623 | LifeSPARC Pump, LifeSPARC Controller | Cardiacassist, Inc. | 2019 | Class I |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 1 |
| 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? (3)
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 |
|---|---|---|---|
| * | K991783 | AB-180 XC System, Model AB-180XCSummary page 4…fication Name: Pump, Blood, Non-Roller Type Cardiopulmonary Bypass (21 CFR Part 870.4360 / Code 74 KFM) Predicate Devices CardiacAssist AB-180 XC System (K991783) Levitronix Centrimag Extracorporeal Blood Pumping System (K020271) Levitronix/Thoratec Centrimag Primary Console (K0… | 2000 |
| * | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Summary page 4…CFR Part 870.4360 / Code 74 KFM) Predicate Devices CardiacAssist AB-180 XC System (K991783) Levitronix Centrimag Extracorporeal Blood Pumping System (K020271) Levitronix/Thoratec Centrimag Primary Console (K083340) Device Description The TandemHeart System consists of two… | 2003 |
| * | K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleSummary page 4…CardiacAssist AB-180 XC System (K991783) Levitronix Centrimag Extracorporeal Blood Pumping System (K020271) Levitronix/Thoratec Centrimag Primary Console (K083340) Device Description The TandemHeart System consists of two major components, the Escort Controller (K061369), and… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183623 | LifeSPARC Pump, LifeSPARC Controller Class I | 2019 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2020 | Class II | Z-1955-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1954-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1948-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1951-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1950-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1953-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1952-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
| Mar 6, 2020 | Class II | Z-1949-2020 | Under Investigation by firm | Failure to prime due to an assembly error |
The 5 latest of 8 recalls; the web page lists all.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183623 (Cardiacassist, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K991783.
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. 2011, 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 TandemHeart pump 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/K110493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110493: Tandemheart Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110493
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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