510(k) · Cleared
Recalled · Class II · 2026M3290B Philips IntelliVue Information Center iX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 13, 2016 as substantially equivalent to K143057 (Philips Medical Systems, 2014) after a 173-day review. Its family tree reaches back 24 generations to 1994. 3 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 13, 2016
- Review
- 173 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 24 generations to K941811 (1994). 136 ancestors in all, the oldest K872781 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 24 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 20 generations between
- 3 generations backK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · Recalled
- 2 generations backK102495 M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010 · Recalled
- 1 generation backK143057 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · Recalled
- This deviceK153702 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016
- Descendant · cites it directly · 2 of its ownK163584 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017
- Descendant · 2 generations on · 0 of its ownK183387 M3290B Patient Information Center iXPhilips Medical Systems · 2019
- Descendant · 2 generations on · 0 of its ownK173203 Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx · 2018
Show all 24 generations
- Root · 24 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 23 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 22 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 21 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 20 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 19 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 18 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 17 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 16 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 15 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 14 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 13 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 12 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 11 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 10 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 9 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 8 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 7 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 6 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 5 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 4 generations backK062271 M3290A Intellivue Information Center Software, Release J.00 (for…Philips Medical Systems · 2006 · Recalled
- 3 generations backK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · Recalled
- 2 generations backK102495 M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010 · Recalled
- 1 generation backK143057 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · Recalled
- This deviceK153702 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016
Most influential descendants
Showing 3 of 3 · See all- K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017 · cites it directly2descendants
- K183387M3290B Patient Information Center iXPhilips Medical Systems · 2019 · 2 generations on0descendants
- K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −23 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −22 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −21 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −20 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −19 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −18 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −17 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −16 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −15 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −14 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −13 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −12 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −11 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −10 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −9 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −8 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −7 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −6 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −5 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −4 | K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145… | Philips Medical Systems | 2006 | 3 |
| −3 | K081983 | M3290A Intellivue Information Center Software, Release 1.00 | Philips Medical Systems | 2008 | 3 |
| −2 | K102495 | M3290B Intellivue Information Center Software, Release a.0 | Philips Medical Systems | 2010 | 7 |
| −1 | K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014 | 1 |
| 0 (this device) | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | — |
| +1 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | — |
| +2 | K183387 | M3290B Patient Information Center iX | Philips Medical Systems | 2019 | — |
| +2 | K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 6 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 17 | 0 |
| 2001 | 5 | 0 |
| 2002 | 10 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K143057 | M3290B Philips IntelliVue Information Center iXSummary page 4…. Predicate device information Trade name: M3290B Philips IntelliVue Information Center iX software Revision B.01 Manufacturer: Philips Medical Systems 510(k) clearance: K143057 Page 1 of 5 K153702 p.2/5… | 2014 |
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 |
|---|---|---|---|
| K163584 | M3290B Philips IntelliVue Information Center iX | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2026 | Class II | Z-3142-2026 | Software design | Due to software malfunction, patient information system may freeze and become unresponsive. |
| Jul 31, 2026 | Class II | Z-3141-2026 | Software design | Due to software malfunction, patient information system may freeze and become unresponsive. |
| Dec 22, 2025 | Class II | Z-1156-2026 | Software Design Change | A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. |
| Apr 19, 2024 | Class II | Z-1827-2024 | Software design | Event Catalog information does not save when copied and transferred from one unit to another. |
| Mar 22, 2024 | Class II | Z-1690-2024 | Component design/selection | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the… |
| Feb 28, 2024 | Class II | Z-1386-2024 | Under Investigation by firm | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
| Feb 15, 2024 | Class II | Z-3312-2024 | Device Design | If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which… |
| Nov 28, 2023 | Class II | Z-0731-2024 | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. |
| Nov 28, 2023 | Class II | Z-0732-2024 | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. |
| Aug 17, 2023 | Class II | Z-2608-2023 | Under Investigation by firm | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring.… |
| Apr 19, 2023 | Class II | Z-0035-2025 | Software design | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address… |
| Apr 29, 2019 | Class III | Z-1771-2019 | Software design | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 16 of the 136 ancestors have a recall of any class.
- Of its descendants, K163584 (Philips Medical Systems, 2017) has gone furthest, with 2 descendants of its own.
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 intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the…
Read the full statement (160 words)
The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database.
An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
This product is intended for use in health care facilities by trained healthcare professionals. This product is not intended for home use.
Indicated for central monitoring of multiple adult and all pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) 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.
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/K153702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153702: M3290B Philips IntelliVue Information Center iX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153702
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