510(k) · Cleared
ClearedOmni II Patient Monitor
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 Jun 2, 2011 as substantially equivalent to K103268 (Infinium Medical, 2010) after a 162-day review. Its family tree reaches back 3 generations to 2003. 4 later devices descend from it.
- Decided
- Jun 2, 2011
- Review
- 162 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021154 (2003). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK021154 Goldway Patient Monitor, Model # UT4000FGoldway Us, Inc. · 2003
- 2 generations backK101052 Omni Iii Patient MonitorInfinium Medical · 2010
- 1 generation backK103268 Omni ExpressInfinium Medical · 2010
- This deviceK103737 Omni II Patient MonitorInfinium Medical · 2011
- Descendant · cites it directly · 3 of its ownK112329 Omni Patient MonitorInfinium Medical · 2011
- Descendant · cites it directly · 2 of its ownK132229 Omni Patent MonitorsInfinium Medical · 2014
- Descendant · cites it directly · 0 of its ownK153079 Axeo 3 Patient MonitorAxeo Medical Technologies, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK142244 Cleo Patient MonitorInfinium Medical · 2015 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K112329Omni Patient MonitorInfinium Medical · 2011 · cites it directly3descendants
- K132229Omni Patent MonitorsInfinium Medical · 2014 · cites it directly2descendants
- K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC · 2016 · cites it directly0descendants
- K142244Cleo Patient MonitorInfinium Medical · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021154 | Goldway Patient Monitor, Model # UT4000F | Goldway Us, Inc. | 2003 | — |
| −2 | K101052 | Omni Iii Patient Monitor | Infinium Medical | 2010 | — |
| −1 | K103268 | Omni Express | Infinium Medical | 2010 | — |
| 0 (this device) | K103737 | Omni II Patient Monitor | Infinium Medical | 2011 | — |
| +1 | K112329 | Omni Patient Monitor | Infinium Medical | 2011 | — |
| +1 | K132229 | Omni Patent Monitors | Infinium Medical | 2014 | — |
| +1 | K153079 | Axeo 3 Patient Monitor | Axeo Medical Technologies, LLC | 2016 | — |
| +2 | K142244 | Cleo Patient Monitor | Infinium Medical | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K103268 | Omni ExpressSummary page 2…monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. Predicate Device: K103268 - 0MNI Express Patient Monitor Substantial Equivalence: The proposed device is substantially equivalent to the… | 2010 |
What descends from it? (4)
3 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 8 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112329 (Infinium Medical, 2011) has gone furthest, with 3 descendants of its own.
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. 2011, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103737: Omni II 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/K103737
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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