510(k) · Cleared
Recalled · Class II · 2020Surveyor S4 Mobile Monitor
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 Aug 4, 2016 as substantially equivalent to K141020 (Mortara Instrument, Inc., 2014) and 1 other predicate after a 146-day review. Its family tree reaches back 6 generations to 1994. It has been recalled once.
- Decided
- Aug 4, 2016
- Review
- 146 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933143 (1994). 31 ancestors in all, the oldest K781836 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 5 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 4 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 3 generations backK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- 2 generations backK081800 T12S Telemetry TransmitterMortara Instrument, Inc. · 2008 · Recalled
- 1 generation backK141020 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2014
- This deviceK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −5 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −4 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −3 | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| −2 | K081800 | T12S Telemetry Transmitter | Mortara Instrument, Inc. | 2008 | 1 |
| −1 | K141020 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2014 | — |
| 0 (this device) | K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K141020 | Surveyor S4 Mobile MonitorSummary page 5…are no previous submissions for this device 3. Predicate Device to which this is Substantially Equivalent Surveyor S4 Mobile Monitor K141020 ApexPro Telemetry System K080251 The primary predicate device is Surveyor S4 Mobile Monit… | 2014 |
| * | K080251 | Apexpro Telemetry SystemsSummary page 5…to which this is Substantially Equivalent Surveyor S4 Mobile Monitor K141020 ApexPro Telemetry System K080251 The primary predicate device is Surveyor S4 Mobile Monitor, K141020. The S4 predicate device has not been subject to… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2020 | Class II | Z-1815-2020 | Device Design | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K141020.
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. 2016, 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 S4 Mobile Monitor is indicated for use: The Surveyor S4 is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own. The Surveyor S4…
Read the full statement (194 words)
The Surveyor S4 Mobile Monitor is indicated for use:
The Surveyor S4 is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.
The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm
The Surveyor S4 can deliver data from a 3/5 lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station.
The Surveyor S4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.
The Surveyor S4 mobile monitor is indicated for use in adults, adolescents and children.
The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160685: Surveyor S4 Mobile Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160685
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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