# K090051: Levitronix Pedimag Blood Pump, Model 201-90052

- Pathway: 510(k) (Traditional)
- Applicant: Levitronix, LLC
- Decided: Oct 8, 2009 after 274 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). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 10 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.
- K852807: Bio Medicus Bio Pump Model BP-50, Bio Medicus, Inc. (1985) Summary page 1.

## Most influential descendants
- K220842: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (2023), 1 descendant of its own
- K251762: Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (2025), 0 descendants of its own

## Recalls of this device
- 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

## Indications for use
The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.). The PediMag Pump can generate a maximum pump flow equal to 1.5 liters per minute, limiting its use to pediatric patients. The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor.

Source page: https://510kreport.com/device/K090051
Methodology: https://510kreport.com/methodology