# K133658: Cdi Blood Parameter Monitoring System 500

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jul 25, 2014 after 240 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K033926: Hourglass Vertebral Body Spacer, Medtronic Sofamor Danek (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K182110: CDI Blood Parameter Monitoring System 550 (2018), 1 descendant of its own
- K234065: CDI OneView Monitoring System (2024), 0 descendants of its own

## Recalls of this device
- Jun 26, 2018 · Class II · Z-2750-2018: H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the 
- Jun 26, 2018 · Class II · Z-2751-2018: H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the 
- Mar 14, 2016 · Class II · Z-1250-2016: Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in
- Aug 7, 2015 · Class II · Z-2742-2015: Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

## Indications for use
The CDI™ System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

Source page: https://510kreport.com/device/K133658
Methodology: https://510kreport.com/methodology