510(k) · Cleared
ClearedMural Clinical Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 21, 2022 as substantially equivalent to K141811 (Mortara Instrument, Inc., 2014) after a 117-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Dec 21, 2022
- Review
- 117 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933143 (1994). 8 ancestors in all, the oldest K922927 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 4 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 3 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 2 generations backK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
- 1 generation backK141811 Mortara Monitoring Waveform ViewerMortara Instrument, Inc. · 2014
- This deviceK222586 Mural Clinical ViewerGe Medical Systems Information Technologies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −4 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −3 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −2 | K131929 | Surveyor Central Station | Mortara Instrument, Inc. | 2013 | — |
| −1 | K141811 | Mortara Monitoring Waveform Viewer | Mortara Instrument, Inc. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K141811 | Mortara Monitoring Waveform ViewerSummary page 4…II Product Code MHX Review Panel Cardiovascular 807.92(a)(3) – Predicate Device 510(k) Number K141811 Manufacturer Mortara Instruments, Inc. Predicate Device(s) Mortara Monitoring Waveform Viewer… | 2014 |
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 28 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
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. 2022, 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?
Mural Clinical Viewer is a patient monitoring software application intended for the electronic collection, display, trending, annotation, measurement and export of clinical data. Data is acquired from medical devices, Electronic Health Records (EHRs) and other data sources on a hospital's network. The application is designed to accept a patient selection from a host Electronic Health Record (EHR) program and then display that particular patient's data…
Read the full statement (150 words)
Mural Clinical Viewer is a patient monitoring software application intended for the electronic collection, display, trending, annotation, measurement and export of clinical data. Data is acquired from medical devices, Electronic Health Records (EHRs) and other data sources on a hospital's network. The application is designed to accept a patient selection from a host Electronic Health Record (EHR) program and then display that particular patient's data and waveforms within the EHR. The device is intended to be used by healthcare professionals in general hospital (including ICU) or remote clinical support settings while operating within a single patient's EHR.
This product does not control or alter any of the medical devices providing data across the hospital network. All information, alerts or visual indications provided are intended to support the judgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222586 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222586: Mural Clinical Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222586
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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