# K132229: Omni Patent Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Infinium Medical
- Decided: Feb 21, 2014 after 218 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: 7 generations back to K933143 (1994). 39 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062098: Spectrum Monitor, Model 0998-00-1000-Xxxxx, Datascope Corp. (2007) Summary page 6.
- K112329: Omni Patient Monitor, Infinium Medical (2011)
- K103737: Omni II Patient Monitor, Infinium Medical (2011) Summary page 6.
- K101052: Omni Iii Patient Monitor, Infinium Medical (2010) Summary page 7.

## Cited in the summary but kept off the family tree
- K103726: Jarit Take-Apart Endoscopic Instruments, Integra LifeSciences Corporation (2012). Our reading of the summary gave K103726, FDA’s number for Jarit Take-Apart Endoscopic Instruments (Integra LifeSciences Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “OMNI Express Patient Monitor”. Kept off the family tree. Summary page 7.

## Most influential descendants
- 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 patient monitor is to monitor basic physiological parameters including * ECG waveform derived from 3, 5 or 12 lead measurements * Heart Rate * NIBP(systolic, diastolic, and mean arterial pressure) * SPO2 * Respiration * Temperature - up to 2 channels (Dual Temperature) * CO2 * IBP * Anesthetic agents 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. The purpose and function of the OMNI 11 patient monitor is to monitor basic physiological parameters including * ECG waveform derived from 3, 5 or 12 lead measurements * Heart Rate * NIBP(systolic, diastolic, and mean arterial pressure) * SPO2 * Respiration * Temperature - up to 2 channels (Dual Temperature) * CO2 * Cardiac Output * IBP * Anesthetic agents The target population is for adult, neonate and pediatric patients with the exception of: * Cardiac Output for which the target population is adult only. 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. The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including * ECG waveform derived from 3, 5 or 12 lead measurements * Heart Rate * NIBP(systolic, diastolic, and mean arterial pressure) * SPO2 * Respiration * Temperature - up to 2 channels (Dual Temperature) * CO2 * Cardiac Output * IBP * Anesthetic agents The target population is for adult, neonate and pediatric patients with the exception of: * Cardiac Output for which the target population is adult only. 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. The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including * ECG waveform derived from 3 to 5 lead measurements * Heart Rate * NIBP(systolic, diastolic, and mean arterial pressure) * SpO2 * Respiration * Temperature - up to 2 channels (Dual Temperature) * CO2 * Anesthetic agents 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.

Source page: https://510kreport.com/device/K132229
Methodology: https://510kreport.com/methodology