510(k) · Cleared
ClearedMortara Monitoring Waveform Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 19, 2014 as substantially equivalent to K131929 (Mortara Instrument, Inc., 2013) after a 135-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Nov 19, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933143 (1994). 7 ancestors in all, the oldest K922927 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 2 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 1 generation backK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
- This deviceK141811 Mortara Monitoring Waveform ViewerMortara Instrument, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK222586 Mural Clinical ViewerGe Medical Systems Information Technologies, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222586Mural Clinical ViewerGe Medical Systems Information Technologies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −2 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −1 | K131929 | Surveyor Central Station | Mortara Instrument, Inc. | 2013 | — |
| 0 (this device) | K141811 | Mortara Monitoring Waveform Viewer | Mortara Instrument, Inc. | 2014 | — |
| +1 | K222586 | Mural Clinical Viewer | Ge Medical Systems Information Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K131929 | Surveyor Central StationSummary page 4…ich S.E. is claimed: Mortara Monitoring Waveform Predicate 510(k) Number Predicate Manufacturer / Model Viewer Surveyor Central Station K131929 Mortara Instrument, Inc. / Surveyor… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222586 | Mural Clinical Viewer | 2022 | 0 |
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 1 company; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K222586 (Ge Medical Systems Information Technologies, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131929.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With 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 · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Monitoring Waveform Viewer is indicated for use as follows: The Monitoring Waveform Viewer is a software component utilized within another software application. The Monitoring Waveform Viewer performs the following: • Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters. • Display of reported alarm states produced by such monitoring systems. • Display of static waveforms for review of…
Read the full statement (192 words)
The Monitoring Waveform Viewer is indicated for use as follows:
The Monitoring Waveform Viewer is a software component utilized within another software application.
The Monitoring Waveform Viewer performs the following:
• Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters.
• Display of reported alarm states produced by such monitoring systems.
• Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon.
• Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waveform Viewer displays still waveforms.
• Provide selected waveform episodes to the host application for printing or inclusion in the patient record.
The Monitoring Waveform Viewer:
• Is not a primary or secondary alarm device.
• Does not provide a user interface for acknowledging or silencing active alarms.
• Does not generate audible or visual (flashing) notifications of active alarms.
The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141811: Mortara Monitoring Waveform Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141811
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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