510(k) · Cleared
ClearedAxeo 3 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axeo Medical Technologies, LLC · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 17, 2016 as substantially equivalent to K132229 (Infinium Medical, 2014) and 1 other predicate after a 146-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Mar 17, 2016
- Review
- 146 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K933143 (1994). 40 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 7 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 6 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 5 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 4 generations backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- 3 generations backK031849 Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. · 2003 · Recalled
- 2 generations backK062098 Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007
- 1 generation backK132229 Omni Patent MonitorsInfinium Medical · 2014
- This deviceK153079 Axeo 3 Patient MonitorAxeo Medical Technologies, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −7 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −6 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −5 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −4 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| −3 | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | Datascope Corp. | 2003 | 1 |
| −2 | K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | 2007 | — |
| −1 | K132229 | Omni Patent Monitors | Infinium Medical | 2014 | — |
| 0 (this device) | K153079 | Axeo 3 Patient Monitor | Axeo Medical Technologies, LLC | 2016 | — |
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 |
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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132229 | Omni Patent MonitorsSummary page 5…technological characteristics of ECG, Heart Rate, NIBP, SpO2, Respiration, and Temperature as the Omni II Patient Monitor which is one of the monitors cleared as part of K132229, Omni Patient Monitor (models: Omni, Omni II, Omni III, and Omni Express). The Axeo 3 Patient Monitor is also substantially equiv… | 2014 |
| * | K103737 | Omni II Patient MonitorSummary page 6…Page 2 of 4 510(k) Summary and Temperature as the Omni II Patient Monitor which was cleared in K103737, Omni II Patient Monitor. These predicates have not been subject to design-related recalls. No reference devices were used in thi… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 10 of the 40 ancestors have a recall of any class.
- 1 other device also cites its predicate K132229.
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. 2016, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153079: Axeo 3 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153079
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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