# K153079: Axeo 3 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Axeo Medical Technologies, LLC
- Decided: Mar 17, 2016 after 146 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933143 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 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.
- K103737: Omni II Patient Monitor, Infinium Medical (2011) Summary page 6.

## Indications for use
The purpose and function of the AXEO 3 patient monitor is to monitor basic physiological parameters including • ECG waveform derived from 3 or 5 lead measurements • Heart Rate • NIBP (systolic, diastolic, and mean arterial pressure) • SpO2 • Respiration • Temperature – up to 2 channels (Dual Temperature) The target population is for adult, neonate and pediatric patients. 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. This device is not intended for use as an apnea monitor.

Source page: https://510kreport.com/device/K153079
Methodology: https://510kreport.com/methodology