# K051209: Levitronix Centrimag Back-UP Console

- Pathway: 510(k) (Special)
- Applicant: Levitronix, LLC
- Decided: Sep 8, 2005 after 120 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K852698 (1985). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100, Levitronix, LLC (2003) Summary page 1.

## Most influential descendants
- K090004: Levitronix, Thoratec Centrimag Back-UP Consoles (2009), 1 descendant of its own
- K093832: Levitronix Centrimag Primary and Backup Consoles (2010), 0 descendants of its own

## Recalls of this device
- Mar 17, 2008 · Not classified · Z-1902-2008: Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

## Indications for use
The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. 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/K051209
Methodology: https://510kreport.com/methodology