# K142244: Cleo Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Infinium Medical
- Decided: Feb 6, 2015 after 177 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933143 (1994). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132229: Omni Patent Monitors, Infinium Medical (2014) Summary page 5.
- K053174: Loflo C5 CO2 Sensor, Respironics Novametrix, LLC (2006) Summary page 5.

## Recalls of this device
- May 31, 2019 · Class II · Z-1926-2019: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

## Indications for use
The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including NIBP (systolic and diastolic) SpO2 ETCO2 The target population is for adults only. It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K142244
Methodology: https://510kreport.com/methodology