# K902654: Cdi (TM) System 100 Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Ltd.
- Decided: Nov 5, 1990 after 143 days
- Product code: DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4410
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972962: 3M Cdi Blood Parameter Monitoring System 500 (1997), 10 descendants of its own
- K110957: M4 Monitor (2011), 4 descendants of its own
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), 3 descendants of its own
- K090147: Blood Monitoring Unit, Model Bmu 40 (2009), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own

## Recalls of this device
- Apr 28, 2011 · Not classified · Z-2610-2011: Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen
- Apr 21, 2011 · Not classified · Z-2684-2011: Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the 
- Apr 21, 2011 · Not classified · Z-2683-2011: Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the 
- Nov 1, 2010 · Not classified · Z-1943-2011: Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
- Nov 1, 2010 · Not classified · Z-1944-2011: Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.

Source page: https://510kreport.com/device/K902654
Methodology: https://510kreport.com/methodology