510(k) · Cleared
ClearedSurveyor Central Station
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 Dec 3, 2013 as substantially equivalent to K060135 (Mortara Instrument, Inc., 2006) and 1 other predicate after a 159-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Dec 3, 2013
- Review
- 159 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933143 (1994). 6 ancestors in all, the oldest K922927 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 2 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 1 generation backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- This deviceK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK141811 Mortara Monitoring Waveform ViewerMortara Instrument, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK222586 Mural Clinical ViewerGe Medical Systems Information Technologies, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · cites it directly3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 2 generations on2descendants
- K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 3 generations on1descendant
- K141811Mortara Monitoring Waveform ViewerMortara Instrument, Inc. · 2014 · cites it directly1descendant
- K222586Mural Clinical ViewerGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −2 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −1 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| 0 (this device) | K131929 | Surveyor Central Station | Mortara Instrument, Inc. | 2013 | — |
| +1 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +2 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +3 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | — |
| +1 | K141811 | Mortara Monitoring Waveform Viewer | Mortara Instrument, Inc. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K060135 | Mortara Surveyor Telemetry Central StationSummary page 1…which S.E. is claimed: Mortara Surveyor Central Station Predicate 510(k) Number Predicate Manufacturer/ Model Patient Monitoring K060135 Mortara Instrument, Inc. ISurveyor… | 2006 |
| * | K082946 | Mortara Eli 350 ElectrocardiographSummary page 1…ra Instrument, Inc. ISurveyor Telemetry Central Station Electrocardiograph K082946 Mortara Instrument, Inc. / ELI 350… | 2008 |
What descends from it? (6)
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 19 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133973 (Remote Diagnostic Technologies, Ltd., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K060135.
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. 2013, 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 Surveyor Central System is indicated for use: * In a clinical setting, by qualified medical professionals, properly trained for patient monitoring and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. * Centralized monitoring through a network of patients in Coronary Care Units…
Read the full statement (151 words)
The Surveyor Central System is indicated for use:
* In a clinical setting, by qualified medical professionals, properly trained for patient monitoring and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements.
* Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
* Chest Pain Evaluation.
* Evaluation of patients with pacemakers.
* Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after MlI. or cardiac surgery.)
* Evaluation of monitored parameters documenting therapeutic Interventions in individual patients or groups of patients.
* Clinical and epidemiological research studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131929: Surveyor Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131929
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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