# K011835: Cobe Revolution

- Pathway: 510(k) (Abbreviated)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Feb 12, 2002 after 245 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: 1 generation back to K852698 (1985). 1 ancestor in all.
12 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852698: Bio Medicus Bio Pump Model BP-80, Bio Medicus, Inc. (1985) Summary page 1.

## Most influential descendants
- K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 (2003), 9 descendants of its own
- K192850: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (2020), 4 descendants of its own
- K202169: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (2020), 3 descendants of its own
- K030154: Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator (2003), 3 descendants of its own
- K201320: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (2021), 2 descendants of its own

## Recalls of this device
- Sep 25, 2009 · Not classified · Z-0192-2010: A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

## Indications for use
The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stéckert Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

Source page: https://510kreport.com/device/K011835
Methodology: https://510kreport.com/methodology