# K080470: Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Sep 12, 2008 after 204 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.
4 later devices descend from it; 2 cite it directly.
2 of 5 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) RotaFlow Centrifugal Pump with Safeline Coating: named in the summary without a submission number
- (no number) Quadrox D Diffusion Membrane Oxygenator with Bioline Coating: named in the summary without a submission number

## Most influential descendants
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own
- K090515: Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa) (2009), 0 descendants of its own

## Recalls of this device
- Jan 8, 2024 · Class II · Z-0977-2024: 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
- Feb 23, 2016 · Class II · Z-1373-2016: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

## Indications for use
The Rotaflow Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: * Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vesscls: or * Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K080470
Methodology: https://510kreport.com/methodology