510(k) Report

510(k) · Cleared

Cleared

Mortara Surveyor Telemetry Central Station

K060135510(k) AbbreviatedCleared May 15, 2006116-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mortara Instrument, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 15, 2006 as substantially equivalent to K922927 (Mortara Instrument, Inc., 1992) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1992. 10 later devices descend from it.

Decided
May 15, 2006
Review
116 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K922927 (1992). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2013: 2 descendants cleared2017: 2 descendants cleared2014: 2 descendants cleared2022: 1 descendant cleared2018: 2 descendants cleared2020: 1 descendant clearedK922927 · Mortara Instrument ST Central Station · Mortara Instrument, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K922927 · Mortara Instrument ST Central Station · Mortara Instrument, Inc. · 19920+5
  1. Root · 1 generation backK922927 Mortara Instrument ST Central StationMortara Instrument, Inc. · 1992
  2. This deviceK060135 Mortara Surveyor Telemetry Central StationMortara Instrument, Inc. · 2006
  3. Descendant · cites it directly · 6 of its ownK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
  4. Descendant · 2 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
  5. Descendant · 3 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
  6. Descendant · cites it directly · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
  7. Descendant · 4 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013: 22014: 22017: 22018: 22020: 12022: 1
2013high 2 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all
  • K131929Surveyor Central StationMortara Instrument, Inc. · 2013 · cites it directly6descendants
  • K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 2 generations on3descendants
  • K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 3 generations on2descendants
  • K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · cites it directly2descendants
  • K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922927Mortara Instrument ST Central StationMortara Instrument, Inc.1992—
0 (this device)K060135Mortara Surveyor Telemetry Central StationMortara Instrument, Inc.2006—
+1K131929Surveyor Central StationMortara Instrument, Inc.2013—
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.2014—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.2017—
+1K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.20131
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201420
201720
201820
202010
202210
FIG. 1 — Lineage of K060135, 1992–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K922927Mortara Instrument ST Central Station
Summary page 1
…which S. E. is claimed The Surveyor Telemetry Central Station is an evolution of a legally marketed Mortara predicate device. * Mortara Model ST Central Station, (K922927) * Datex-Ohmeda S/3 Telemetry Central System (K 000882) Description: The Surveyor Telemetry Central Station is a diagnos…
Mortara Instrument, Inc.1992—
*K000882Datex-Ohmeda CS/3 Telemetry System
Summary page 1
…is an evolution of a legally marketed Mortara predicate device. * Mortara Model ST Central Station, (K922927) * Datex-Ohmeda S/3 Telemetry Central System (K 000882) Description: The Surveyor Telemetry Central Station is a diagnostic tool intended to acquire, and provide real time ECG data o…
Datex-Ohmeda2000—

Also cleared against K922927: 1 other device →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131929Surveyor Central StationMortara Instrument, Inc.20136
K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.20132

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K131929 (Mortara Instrument, Inc., 2013) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K922927.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

The Surveyor Central Telemetry System Is indicated for use: * in a clinical setting, by qualified medical professionals, properly trained for ECG 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 ECG monitoring through a telemetry network of adult patients in…

Read the full statement (156 words)

The Surveyor Central Telemetry System Is indicated for use:

* in a clinical setting, by qualified medical professionals, properly trained for ECG 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 ECG monitoring through a telemetry network of adult patients in Coronary Care Units, Step-Down Units, Emergency Departments. It is not designed for use in highly invasive environments, such as an operating theatre.

* Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.

* Chest Pain Evaluation.

* Evaluation of adult patients with pacemakers.

* Evaluation of a patient's response after resuming occupational or recreational activities (e.g.. after M.I. or cardiac surgery.)

* Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

* Clinical and epidemiological research studies.

Indications for use as stated in the FDA summary.

Also cleared against K922927

1 other device cites the same predicate.

  • K942685Ecg Review StationMortara Instrument, Inc. · 1997

More from Mortara Instrument, Inc.

51 FDA decisions under this applicant name. See the company

  • K182297Surveyor S2Mortara Instrument, Inc. · 2019
  • K173765Surveyor Patient MonitorMortara Instrument, Inc. · 20182 recalls
  • K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
  • K161465CardioConfirmMortara Instrument, Inc. · 2016
  • K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 20161 recall

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K060135 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060135: Mortara Surveyor Telemetry Central Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060135

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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