# K030462: Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700

- Pathway: 510(k) (Special)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Mar 6, 2003 after 22 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 K922933 (1992). 7 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011835: Cobe Revolution, Cobe Cardiovascular, Inc. (2002)
- K004001: Monolyth Mimesys Hollow Fiber Oxygenator, Dideco (2001)
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator, Dideco S.P.A. (2002)

## Most influential descendants
- 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
- K201320: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (2021), 2 descendants of its own
- K032040: Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator (2003), 2 descendants of its own
- K050890: Ecc.O System (2005), 1 descendant of its own

## Recalls of this device
- Sep 25, 2009 · Not classified · Z-0193-2010: A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

## Indications for use
The pump is intended for use only with Stockert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. 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).

Source page: https://510kreport.com/device/K030462
Methodology: https://510kreport.com/methodology