# K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: May 23, 2006 after 36 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932252 (1993). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 4.
- K992559: Hollow Fiber Membrane Oygenator Quadrox Hmo 1010, Jostra Bentley (1999) Summary page 4.
- K030264: Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030, Jostra AG (2003) Summary page 4.

## Most influential descendants
- K061743: Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum Tight, Model BSQ-VHK 2001 (2006), 3 descendants of its own
- K090534: Venous Hardshell Cardiotomy Reserviors (2009), 2 descendants of its own
- K072583: Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30 (2008), 2 descendants of its own
- K102919: Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe (2011), 1 descendant of its own
- K090555: Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 (2009), 1 descendant of its own

## 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 vessels; 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/K061072
Methodology: https://510kreport.com/methodology