# K101052: Omni Iii Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Infinium Medical
- Decided: Aug 11, 2010 after 118 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: 1 generation back to K021154 (2003). 1 ancestor in all.
6 later devices descend from it; 2 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)
- K021154: Goldway Patient Monitor, Model # UT4000F, Goldway Us, Inc. (2003) Summary page 2.

## Most influential descendants
- K103268: Omni Express (2010), 5 descendants of its own
- K103737: Omni II Patient Monitor (2011), 4 descendants of its own
- 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

## Indications for use
The purpose and function of the OMNI Ill patient monitor is to monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SPO 2, respiration, and temperature for adult, neonate dnd 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/K101052
Methodology: https://510kreport.com/methodology