510(k) · Cleared
Recalled · Class II · 2013Endeavour Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mindray DS USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 10, 2010 as substantially equivalent to K062098 (Datascope Corp., 2007) and 1 other predicate after a 57-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 10, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933143 (1994). 34 ancestors in all, the oldest K842616 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 6 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 5 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 4 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 3 generations backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- 2 generations backK031849 Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. · 2003 · Recalled
- 1 generation backK062098 Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007
- This deviceK102004 Endeavour Monitoring SystemMindray DS USA, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK132026 V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc. · 2013 · cites it directly2descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −6 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −5 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −4 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −3 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| −2 | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | Datascope Corp. | 2003 | 1 |
| −1 | K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | 2007 | — |
| 0 (this device) | K102004 | Endeavour Monitoring System | Mindray DS USA, Inc. | 2010 | — |
| +1 | K132026 | V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 | Mindray DS USA, Inc. | 2013 | 1 |
| +2 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
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 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K062098 | Spectrum Monitor, Model 0998-00-1000-XxxxxSummary page 1…§870.1435- DXG - Single-function, pre-programmed diagnostic computer Predicate Devices: Spectrum Monitor - K062098 Accutorr Plus Monitor -K983575 Device description: The Endeavour Monitoring System is… | 2007 |
| * | K983575 | Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XXSummary page 1…computer Predicate Devices: Spectrum Monitor - K062098 Accutorr Plus Monitor -K983575 Device description: The Endeavour Monitoring System is a multi physiological paramete… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132026 | V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2013 | Class II | Z-0389-2014 | Environmental control | Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the… |
| Sep 24, 2012 | Class II | Z-0528-2013 | Nonconforming Material/Component | Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. |
| May 7, 2012 | Class II | Z-2279-2012 | Software design | Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 10 of the 34 ancestors have a recall of any class.
- Of its descendants, K132026 (Mindray DS USA, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K062098.
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. 2010, 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 Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters: * EGG waveform derived from 3, 5, 6 and 12 lead measurements * Heart Rate * Pulse Oximetry (SPO2) * ST Segment Analysis * Arrhythmnia Detection * Non Invasive Blood Pressure (NIBP) * Invasive Blood Pressure…
Read the full statement (157 words)
The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:
* EGG waveform derived from 3, 5, 6 and 12 lead measurements
* Heart Rate
* Pulse Oximetry (SPO2)
* ST Segment Analysis
* Arrhythmnia Detection
* Non Invasive Blood Pressure (NIBP)
* Invasive Blood Pressure (1BP)
* Cardiac Output (GO)
* Respiratory Gasses
* Respiration Rate
* Temperature
The Endeavour Monitor has the capability of performing rV Drug and Hemodynamnic Calculations and interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
* Arrhythmia detection and ST Segment Analysis, for which the target populations are adult
and pediatric only,
* IV Drug Calculations for which the target population is adult only, and
a Cardiac Output for which the target population is adult and pediatric only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102004: Endeavour Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102004
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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