# K234065: CDI OneView Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Apr 25, 2024 after 125 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K133658 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182110: CDI Blood Parameter Monitoring System 550, Terumo Cardiovascular Systems Corporation (2018) Summary page 4.

## Recalls of this device
- May 28, 2025 · Class II · Z-2018-2025: Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient tempera
- Mar 3, 2025 · Class II · Z-1492-2025: During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm w

## Indications for use
The CDI OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration: *Potential of Hydrogen (pH) *Partial Pressure of Carbon Dioxide (pCO2) *Partial Pressure of Oxygen (p02) *Potassium Ion (K+) *Oxygen Saturation (S02) *Hematocrit (HCT) *Hemoglobin (Hgb) *Blood Flow Rate (0) *Cardiac Index (CI) *Base Excess (BE) *Bicarbonate (HCO3-) *Oxygen Consumption (V02) *indexed Oxygen Consumption (VO2i) *Oxygen Delivery (DO2) *indexed Oxygen Delivery (DO2i) *Cerebral Regional Oxygen Saturation (rSO2) *Oxygen Extraction Ratio (O2ER) *Body Surface Area (BSA) *Shunt Sensor Temperature

Source page: https://510kreport.com/device/K234065
Methodology: https://510kreport.com/methodology