# K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100

- Pathway: 510(k) (Abbreviated)
- Applicant: Levitronix, LLC
- Decided: Mar 25, 2003 after 421 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852698 (1985). 5 ancestors in all.
21 later devices descend from it; 10 cite it directly.
4 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 2.
- K941921: Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550, Medtronic Bio-Medicus, Inc. (1994) Summary page 2.

## Most influential descendants
- K053630: Levitronix Centrimag Primary Console (2006), 11 descendants of its own
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console (2008), 10 descendants of its own
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console (2008), 9 descendants of its own
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor (2010), 4 descendants of its own
- K191557: CentriMag Acute Circulatory Support System (2019), 2 descendants of its own

## Recalls of this device
- Aug 22, 2019 · Class I · Z-0221-2020: 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: 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
- Mar 17, 2008 · Not classified · Z-1901-2008: Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

## Indications for use
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).

Source page: https://510kreport.com/device/K020271
Methodology: https://510kreport.com/methodology