510(k) · Cleared
ClearedOmni Patent Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinium Medical · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 21, 2014 as substantially equivalent to K062098 (Datascope Corp., 2007) and 3 other predicates after a 218-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 21, 2014
- Review
- 218 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K933143 (1994). 39 ancestors in all, the oldest K842616 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 6 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 5 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 4 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 3 generations backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- 2 generations backK031849 Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. · 2003 · Recalled
- 1 generation backK062098 Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007
- This deviceK132229 Omni Patent MonitorsInfinium Medical · 2014
- Descendant · cites it directly · 0 of its ownK153079 Axeo 3 Patient MonitorAxeo Medical Technologies, LLC · 2016
- Descendant · cites it directly · 0 of its ownK142244 Cleo Patient MonitorInfinium Medical · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −6 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −5 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −4 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −3 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| −2 | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | Datascope Corp. | 2003 | 1 |
| −1 | K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | 2007 | — |
| 0 (this device) | K132229 | Omni Patent Monitors | Infinium Medical | 2014 | — |
| +1 | K153079 | Axeo 3 Patient Monitor | Axeo Medical Technologies, LLC | 2016 | — |
| +1 | K142244 | Cleo Patient Monitor | Infinium Medical | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062098 | Spectrum Monitor, Model 0998-00-1000-XxxxxSummary page 6…nt in intended use and similar technological characteristics of IBP, C02 , Anesthetic Agents, and 12 Lead EGG to the Datascope Corp. Spectrumi TM Monitor under K062098. The OMNI 11 and OMNI III are Substantially equivalent to the Datascope Corp. Spectrum TM Monitor under K062098 in inten… | 2007 |
| * | K112329 | Omni Patient Monitor | 2011 |
| * | K103737 | Omni II Patient MonitorSummary page 6…al ________________Characteristics and Performance OMNI 11 Patient Monitor K 103737 Intended use tnfiniumn Medical - OMNI Patient Monitors 510k… | 2011 |
| * | K101052 | Omni Iii Patient MonitorSummary page 7…ed Technological Characteristics and Performance OMNI Ill Patient Monitor K 10 1052 Intended use Previously Cleared Technologica… | 2010 |
| Kept off the family tree | K103726 | FDA’s K103726 is Jarit Take-Apart Endoscopic Instruments 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…ed Technological Characteristics and Performance OMNI Express Patient K 1037268 Intended use Monitor Previously Cleared Technologic… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 10 of the 39 ancestors have a recall of any class.
- Of its descendants, K153079 (Axeo Medical Technologies, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062098.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (460 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132229 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132229: Omni Patent Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132229
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026