510(k) · Cleared

Recalled · Class I · 2019

Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100

K020271510(k) AbbreviatedCleared Mar 25, 2003421-day reviewClass II21 CFR 870.4360Recalls 3 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Levitronix, LLC · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cleared on Mar 25, 2003 as substantially equivalent to K973011 (Medtronic Bio-Medicus, Inc., 1998) and 1 other predicate after a 421-day review. Its family tree reaches back 2 generations to 1985. 4 of the 27 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 3 times, including a Class I recall.

Decided: Mar 25, 2003
Review: 421 days
Class: Class II
Product code: KFM
Recalls: 3 (1 Class I)
Predicates: 2

Its longest line of descent runs back 2 generations to K852698 (1985). 5 ancestors in all. 21 later devices descend from it, 10 citing it directly. 4 of the 27 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
1 generation backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
This deviceK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003
Descendant · cites it directly · 11 of its ownK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
Descendant · cites it directly · 10 of its ownK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
Descendant · 2 generations on · 9 of its ownK083340 Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary…Levitronix, LLC · 2008 · Recalled
Descendant · cites it directly · 4 of its ownK102129 Levitronix 2ND Generation Centrimag Primary Console, Levitronix…Levitronix, LLC · 2010
Descendant · cites it directly · 2 of its ownK191557 CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) · 2019

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2005high 3 (2008) · low 0 (2007)2026

Class I recalls in this family

K102726 Cardiohelp Systemcites it directly · 2011
K133598 Cardiohelp System2 generations on · 2014
K183623 LifeSPARC Pump, LifeSPARC Controller2 generations on · 2019

Most influential descendants

Showing 5 of 21 · See all

K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006 · cites it directly11descendants
K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC · 2008 · cites it directly10descendants
K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC · 2008 · 2 generations on9descendants
K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC · 2010 · cites it directly4descendants
K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) · 2019 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K852698	Bio Medicus Bio Pump Model BP-80	Bio Medicus, Inc.	1985	—
−1	K973011	BPX80 Bio-Pump (BPX80)	Medtronic Bio-Medicus, Inc.	1998	—
0 (this device)	K020271	Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100	Levitronix, LLC	2003	—
+1	K053630	Levitronix Centrimag Primary Console	Levitronix, LLC	2006	—
+1	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	K102129	Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor	Levitronix, LLC	2010	—
+1	K191557	CentriMag Acute Circulatory Support System	Thoratec Corporation (Now Part of Abbott)	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	3	0
2009	2	0
2010	2	0
2011	2	1
2013	2	0
2014	1	1
2019	2	1
2020	1	0
2023	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K020271, 1985–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

4 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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K973011	BPX80 Bio-Pump (BPX80) Summary page 2 …Device Name 1 Manufacturer I 510(k) No. Bio-Pump, Model BPX-80 I Medtronic K973011 Device Name I Manufacturer I 51U(K) NO. Bio-Console, Model 550…	Medtronic Bio-Medicus, Inc.	1998	—
*	K941921	Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550 Summary page 2 …Device Name I Manufacturer I 51U(K) NO. Bio-Console, Model 550 I Medtronic K941921 D. Device Description System - The Levitronix CentriMag@Extracorporeal Blood Pumping System is a fault-t…	Medtronic Bio-Medicus, Inc.	1994	1

Also cleared against K973011: 9 other devices →

What descends from it? (21)

See all 21

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053630	Levitronix Centrimag Primary Console	Levitronix, LLC	2006	11
K081221	Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console	Levitronix, LLC	2008	10
K102129	Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor	Levitronix, LLC	2010	4
K191557	CentriMag Acute Circulatory Support System	Thoratec Corporation (Now Part of Abbott)	2019	2
K110493	Tandemheart Pump	Cardiacassist, Inc.	2011	2
K102726	Cardiohelp System Class I	Maquet Cardiopulmonary, AG	2011	2
K090051	Levitronix Pedimag Blood Pump, Model 201-90052	Levitronix, LLC	2009	2
K051209	Levitronix Centrimag Back-UP Console	Levitronix, LLC	2005	2
K131179	Centrimag Primary Console (2ND Generation); Mag Monitor	Thoratec Corp	2013	0
K073631	Orqis Extracorporeal Blood Pumping System, Model BPS-100	Orqis Medical Corporation	2008	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 22, 2019	Class I	Z-0221-2020	Process change control	Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Sep 5, 2018	Class II	Z-0103-2019	Device Design	Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.
Mar 17, 2008	Not classified	Z-1901-2008	Device Design	Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

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.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K053630 (Levitronix, LLC, 2006) has gone furthest, with 11 descendants of its own.
9 other devices also cite its predicate K973011.

How does its category compare?

All KFM devices

KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KFM

2in 2025

2007high 7 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KFM

30in 2023

2007high 534 (2021) · low 16 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KFM

2in 2024

2007high 5 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KFM

249in 2025

2007high 446 (2021) · low 57 (2011)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 Levitronix CentriMag@Extracorporeal Blood Pumping System is indicated to pump

blood through the extracorporeal bypass circuit for extracorporeal circulatory support for

periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for

use in extracorporeal circulatory support systems (for periods up to six hours) not

requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support

during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020271

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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