510(k) · Cleared
ClearedEscort M8 Vital Signs Patient Monitor, Model 3810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Oct 12, 2006 as substantially equivalent to K001775 (Zoe Medical, Inc., 2001) and 4 other predicates after a 77-day review. Its family tree reaches back 5 generations to 1994. 11 later devices descend from it.
- Decided
- Oct 12, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K933143 (1994). 37 ancestors in all, the oldest K842616 (1984). 11 later devices descend from it, 1 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 backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 1 generation backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- This deviceK062144 Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006
- Descendant · cites it directly · 10 of its ownK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK130740 Nightingale Monitoring SystemZoe Medical, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK161517 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK152043 Diagnostic Station DS20Schiller AG · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · cites it directly10descendants
- K130740Nightingale Monitoring SystemZoe Medical, Inc. · 2013 · 2 generations on3descendants
- K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · 2 generations on2descendants
- K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017 · 3 generations on1descendant
- K152043Diagnostic Station DS20Schiller AG · 2016 · 3 generations on1descendant
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 | 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 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −1 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| 0 (this device) | K062144 | Escort M8 Vital Signs Patient Monitor, Model 3810 | Invivo Corporation | 2006 | — |
| +1 | K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009 | 1 |
| +2 | K130740 | Nightingale Monitoring System | Zoe Medical, Inc. | 2013 | — |
| +2 | K123556 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2013 | 1 |
| +3 | K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017 | — |
| +3 | K152043 | Diagnostic Station DS20 | Schiller AG | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | K001775 | Zoe Medical Nightingale Monitoring System | 2001 |
| * | K014294 | Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401…Summary page 2…Zoe Medical Nightingale Monitoring System 510(k) KOO 1775 Escort II + 400 Series (Escort Prism) 510(k) K014294 Polaris 2004 Capnograph 5 10(k) K040011 Masimo SET Radical Pulse Oxim… | 2002 |
| * | K040011 | Polaris 2004 CapnographSummary page 2…Escort II + 400 Series (Escort Prism) 510(k) K014294 Polaris 2004 Capnograph 5 10(k) K040011 Masimo SET Radical Pulse Oximeter 5 10(k) K992340 Datascope Passport 2 with Vie… | 2004 |
| * | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Summary page 2…Polaris 2004 Capnograph 5 10(k) K040011 Masimo SET Radical Pulse Oximeter 5 10(k) K992340 Datascope Passport 2 with View 12 ECG Analysis Module 510(k) K020550 5. Indications for Use T… | 1999 |
| * | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXSummary page 2…Masimo SET Radical Pulse Oximeter 5 10(k) K992340 Datascope Passport 2 with View 12 ECG Analysis Module 510(k) K020550 5. Indications for Use The Escort M8 Vital Signs Patient Monitor is intended for use as a vital signs monitor… | 2002 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | 2009 | 10 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 37 ancestors have a recall of any class.
- Of its descendants, K090556 (Spacelabs Healthcare Medical Equipment (Suzhou) CO, 2009) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K001775.
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.
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 Escort M8 Vital Signs Patient Monitor Model 3810 is intended for use as a vital signs monitor for adult and pediatric patients in a hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062144: Escort M8 Vital Signs Patient Monitor, Model 3810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062144
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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