510(k) · Cleared
Recalled · Class II · 2020M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 21, 2004 as substantially equivalent to K040357 (Philips Medical Systems, Inc., 2004) after a 23-day review. Its family tree reaches back 11 generations to 1994. 155 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 21, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 11 generations to K941811 (1994). 64 ancestors in all, the oldest K872781 (1987). 155 later devices descend from it, 7 citing it directly.
- Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations between
- 3 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 2 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 1 generation backK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
- This deviceK041741 M3290A Intellivue Information Center Software Release F.0 and M4840A…Philips Medical Systems, Inc. · 2004
- Descendant · cites it directly · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · 2 generations on · 123 of its ownK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · 2 generations on · 103 of its ownK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
- Descendant · 3 generations on · 92 of its ownK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · 2 generations on · 90 of its ownK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
Show all 11 generations
- Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 9 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 8 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 7 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 6 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 5 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 4 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 3 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 2 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 1 generation backK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
- This deviceK041741 M3290A Intellivue Information Center Software Release F.0 and M4840A…Philips Medical Systems, Inc. · 2004
Showing 5 of 155 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 155 · See all- K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · cites it directly143descendants
- K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on123descendants
- K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH · 2010 · 2 generations on103descendants
- K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 3 generations on92descendants
- K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on90descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −10 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −9 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −8 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −7 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −6 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −5 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −4 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −3 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −2 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −1 | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A… | Philips Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K041741 | M3290A Intellivue Information Center Software Release F.0 and M4840A Philips… | Philips Medical Systems, Inc. | 2004 | — |
| +1 | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| +2 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +2 | K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boblingen GmbH | 2010 | — |
| +3 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +2 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 12 | 0 |
| 2023 | 12 | 0 |
| 2024 | 11 | 0 |
| 2025 | 17 | 0 |
| 2026 | 10 | 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? (1)
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 |
|---|---|---|---|
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 1…new device is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software and M4840A Philips Telemetry System II,cleared under K040357. 4. The modification is a change that adds support for an additional ECG chest lead (vector), adds NBP limit alarms, an… | 2004 |
What descends from it? (155)
See all 1557 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry… | 2008 | 143 |
| K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue… | 2010 | 37 |
| K103646 | Intellivue MX40 Patient Monitor | 2011 | 16 |
| K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150… | 2006 | 9 |
| K081983 | M3290A Intellivue Information Center Software, Release 1.00 | 2008 | 8 |
| K102495 | M3290B Intellivue Information Center Software, Release a.0 | 2010 | 7 |
| K050128 | Vitalware VMS | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2020 | Class II | Z-1767-2020 | Software design | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs… |
| Mar 5, 2020 | Class II | Z-1766-2020 | Software design | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs… |
| Aug 23, 2019 | Class II | Z-2547-2019 | Process control | Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations |
| Jul 8, 2013 | Class II | Z-1780-2013 | Software Design Change | IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 2 of the 64 ancestors have a recall of any class.
- Of its descendants, K081793 (Philips Medizin Systeme Boeblingen GmbH, 2008) has gone furthest, with 143 descendants of its own.
- 26 other devices also cite its predicate K040357.
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?
M3290A: For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M4840A: For ambulatory and bedside monitoring of ECG and SP 0 2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041741 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041741: M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041741
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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