# K070213: Performer CBP System

- Pathway: 510(k) (Traditional)
- Applicant: Rand S.R.L.
- Decided: Mar 21, 2007 after 58 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: 4 generations back to K915183 (1992). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052555: Medtronic Performer TM CPB, Model R51, PCPB, Rand S.R.L. (2006) Summary page 1.
- 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.
- K961364: Automatic Tubing Clamp System (Atc), Rocky Mountain Research, Inc. (1996) Summary page 1.

## Most influential descendants
- K150530: Level Sensor, Level Sensor Tape (2015), 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 extracorporcal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

Source page: https://510kreport.com/device/K070213
Methodology: https://510kreport.com/methodology