# K182110: CDI Blood Parameter Monitoring System 550

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Nov 2, 2018 after 88 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K133658 (2014). 1 ancestor in all.
1 later device descends 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)
- K133658: Cdi Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems Corp. (2014) Summary page 4.

## Most influential descendants
- K234065: CDI OneView Monitoring System (2024), 0 descendants of its own

## Indications for use
The CDI System 550 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, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.

Source page: https://510kreport.com/device/K182110
Methodology: https://510kreport.com/methodology