510(k) · Cleared
ClearedSurveyor S4 Mobile Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 3, 2014 as substantially equivalent to K974149 (Mortara Instrument, Inc., 1998) and 1 other predicate after a 226-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 3, 2014
- Review
- 226 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933143 (1994). 23 ancestors in all, the oldest K781836 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 4 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 3 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 2 generations backK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- 1 generation backK081800 T12S Telemetry TransmitterMortara Instrument, Inc. · 2008 · Recalled
- This deviceK141020 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK182297 Surveyor S2Mortara Instrument, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −3 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −2 | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| −1 | K081800 | T12S Telemetry Transmitter | Mortara Instrument, Inc. | 2008 | 1 |
| 0 (this device) | K141020 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2014 | — |
| +1 | K182297 | Surveyor S2 | Mortara Instrument, Inc. | 2019 | — |
| +1 | K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 4…S.E. is claimed: Mortara Surveyor S4 Mobile Predicate 510(k) Number Predicate Manufacturer / Model Monitor Ambulatory X-12 Telemetry Module K974149 Mortara Instrument, Inc. / X-12… | 1998 |
| * | K081800 | T12S Telemetry TransmitterSummary page 4…Mortara Instrument, Inc. / X-12 Telemetry Module T12S Telemetry Transmitter K081800 Mortara Instrument, Inc. / T12S… | 2008 |
What descends from it? (2)
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 20 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K182297 (Mortara Instrument, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K974149.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Surveyor S4 Mobile Monitor is indicated for use: • The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals. • The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. • The Surveyor S4 mobile monitor is indicated…
Read the full statement (176 words)
The Surveyor S4 Mobile Monitor is indicated for use:
• The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals.
• The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
• The Surveyor S4 mobile monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The Surveyor S4 mobile monitor is indicated for use to acquire and output electrocardiographic data.
• The Surveyor S4 mobile monitor is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
• The Mortara Li-Ion Battery Charger is intended for charging only the Mortara Rechargeable Li-Ion battery pack.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141020: 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/K141020
Report an extraction error
Are you the manufacturer?
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