# K090515: Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Dec 18, 2009 after 295 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: 7 generations back to K922933 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080470: Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32, Maquet Cardiopulmonary, AG (2008) Summary page 1.
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000, Maquet Cardiopulmonary, AG (2009) Summary page 1.

## Recalls of this device
- Jan 8, 2024 · Class II · Z-0978-2024: Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following p

## Indications for use
The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. -blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.

Source page: https://510kreport.com/device/K090515
Methodology: https://510kreport.com/methodology