# K103737: Omni II Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Infinium Medical
- Decided: Jun 2, 2011 after 162 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: 3 generations back to K021154 (2003). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103268: Omni Express, Infinium Medical (2010) Summary page 2.

## Most influential descendants
- K112329: Omni Patient Monitor (2011), 3 descendants of its own
- K132229: Omni Patent Monitors (2014), 2 descendants of its own
- K153079: Axeo 3 Patient Monitor (2016), 0 descendants of its own
- K142244: Cleo Patient Monitor (2015), 0 descendants of its own

## Indications for use
The purpose and function of the OMNI 11 Patient monitor is to monitor EGG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SPO 2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.

Source page: https://510kreport.com/device/K103737
Methodology: https://510kreport.com/methodology