# K082321: Terumo Rocsafe Hybrid Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Feb 13, 2009 after 184 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: 6 generations back to K915573 (1992). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062381: Capiox RX Oxygenator with or Without Reservoir, Terumo Cardiovascular Systems Corp. (2006) Summary page 2.
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2005) Summary page 2.
- K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir, Terumo Corp. (2004) Summary page 2.
- K020998: Sarns Centrifugal Pump with Xcoating, Model 164275X, Terumo Cardiovascular Systems Corp. (2002) Summary page 2.
- K052205: Capiox AF125X Arterial Filter, Terumo Cardiovascular Systems Corp. (2005) Summary page 2.
- K915265: Cdi (TM) H/S Cuvette, Modification, 3M Company (1992) Summary page 2.
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711, Medtronic Perfusion Systems (2003) Summary page 2.

## Indications for use
The ROCSafeTM Hybrid Perfusion System is a pre-connected extra-corporeal circuit that is designed to offer circulatory support, blood gas maintenance and blood filtration during cardiopulmonary bypass procedures lasting not more than 6-hours in duration. The ROCSafe may only be used with Terumo's System 1 Heart/Lung Pump Platform. The System includes the following: The Capiox RX Hollow Fiber Oxygenators are intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The Capiox RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Oxygenators are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration. The Centrifugal Pump. is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures and is a component of the ROCSafe Hybrid Perfusion System. It is intended to propel blood through the cardiopulmonary bypass circuit. The centrifugal pump is intended to be used in cardioDUlmonary bypass procedures that do not exceed 6_hours in duration. The Capiox AF 125X Arterial Line Blood Filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit for up to 6 hours. The Arterial Filter is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration. The Capiox Venous Bubble Trap is intended to facilitate the removal of air and bubbles from incoming venous blood as it flows into the extra-corporeal bypass circuit. The Bubble Trap is intended to be used in cardiopulmonary bypass procedures that. do not exceed 6 hours in duration. The CDI Cuvette is intended for use with the CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematbcrit, hemoglobin and oxygen saturation is desired. The Cuvettes are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

Source page: https://510kreport.com/device/K082321
Methodology: https://510kreport.com/methodology