# K052555: Medtronic Performer TM CPB, Model R51, PCPB

- Pathway: 510(k) (Traditional)
- Applicant: Rand S.R.L.
- Decided: Mar 15, 2006 after 180 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- 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 K915183 (1992). 7 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960974: Cobe Century Perfusion Pump, Cobe Cardiovascular, Inc. (1997) Summary page 1.
- K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch, Terumo Cardiovascular Systems Corp. (2003) Summary page 1.

## Most influential descendants
- K090006: Lifebridge B2T, Model 7001 (2009), 5 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K070213: Performer CBP System (2007), 1 descendant of its own
- K150530: Level Sensor, Level Sensor Tape (2015), 0 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own

## Recalls of this device
- Jun 4, 2007 · Not classified · Z-1090-2007: Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

## Indications for use
The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when-used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

Source page: https://510kreport.com/device/K052555
Methodology: https://510kreport.com/methodology