# K991864: Rotaflow Centrifugal Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Jostra Medizintechnik AG
- Decided: Aug 31, 2000 after 457 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 9 cite it directly.
4 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic Bio-Medicus Bio-Console Model 550: named in the summary without a submission number
- (no number) Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80: named in the summary without a submission number
- (no number) St. Jude Medical Pulse 2100 Centrifugal Pump Interface: named in the summary without a submission number
- (no number) Medtronic Bio-Probe DP-38: named in the summary without a submission number

## Most influential descendants
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 (2006), 10 descendants of its own
- K011838: Centrifugal Pump (2002), 4 descendants of its own
- K191407: Novalung System (2020), 3 descendants of its own
- K061743: Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum Tight, Model BSQ-VHK 2001 (2006), 3 descendants of its own
- K200109: OXY-1 System (2020), 2 descendants of its own

## Recalls of this device
- Aug 7, 2020 · Class III · Z-2957-2020: Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the 
- Dec 3, 2019 · Class II · Z-0678-2020: A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

## Indications for use
The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Source page: https://510kreport.com/device/K991864
Methodology: https://510kreport.com/methodology