510(k) · Cleared
Recalled · Class II · 2012M3290A Intellivue Information Center Software, Release 1.00
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 Aug 22, 2008 as substantially equivalent to K062271 (Philips Medical Systems, 2006) and 13 other predicates after a 42-day review. Its family tree reaches back 21 generations to 1994. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 22, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 3
- Predicates
- 14
Its longest line of descent runs back 21 generations to K941811 (1994). 133 ancestors in all, the oldest K872781 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 17 generations between
- 3 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 2 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 1 generation backK062271 M3290A Intellivue Information Center Software, Release J.00 (for…Philips Medical Systems · 2006 · Recalled
- This deviceK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008
- Descendant · cites it directly · 7 of its ownK102495 M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK143057 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK153702 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK163584 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017
- Descendant · cites it directly · 1 of its ownK131032 Philips Suresigns CentralPhilips Medical Systems · 2013
Show all 21 generations
- Root · 21 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 20 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 19 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 18 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 17 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 16 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 15 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 14 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 13 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 12 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 11 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 10 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 9 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 8 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 7 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 6 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 5 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 4 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 3 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 2 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 1 generation backK062271 M3290A Intellivue Information Center Software, Release J.00 (for…Philips Medical Systems · 2006 · Recalled
- This deviceK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
2010high 2 (2016) · low 0 (2011)2026
Most influential descendants
Showing 5 of 8 · See all- K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010 · cites it directly7descendants
- K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · 2 generations on4descendants
- K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016 · 3 generations on3descendants
- K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017 · 4 generations on2descendants
- K131032Philips Suresigns CentralPhilips Medical Systems · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −20 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −19 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −18 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −17 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −16 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −15 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −14 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −13 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −12 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −11 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −10 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −9 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −8 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −7 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −6 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −5 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −4 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −3 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −2 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −1 | K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145… | Philips Medical Systems | 2006 | 3 |
| 0 (this device) | K081983 | M3290A Intellivue Information Center Software, Release 1.00 | Philips Medical Systems | 2008 | — |
| +1 | K102495 | M3290B Intellivue Information Center Software, Release a.0 | Philips Medical Systems | 2010 | 7 |
| +2 | K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014 | 1 |
| +3 | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | 12 |
| +4 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | — |
| +1 | K131032 | Philips Suresigns Central | Philips Medical Systems | 2013 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 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? (14)
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 |
|---|---|---|---|
| * | K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Summary page 1…2. The new device is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171,… | 2006 |
| * | K050742 | M3290A Intellivue Information Center Software Release G.00Summary page 1…The new device is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K9648… | 2005 |
| * | K041741 | M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Summary page 1…substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The… | 2004 |
| * | K040955 | M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Summary page 1…ially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modificat… | 2004 |
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 1…ivalent to the previously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made… | 2004 |
| * | K031403 | M3290A Intellivue Information Center Software Release E.1Summary page 1…o the previously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the de… | 2003 |
| * | K023698 | M3290A Intellivue Information Center Software Release E.OSummary page 1…viously cleared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device incl… | 2002 |
| * | K021422 | Philips Information Center Software Revision D.02Summary page 1…leared M3290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the a… | 2002 |
| * | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154Summary page 1…290A IntelliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the addition o… | 2001 |
| * | K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…Summary page 1…lliVue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the addition of the fol… | 2000 |
| * | K000854 | Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry System…Summary page 1…formation Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the addition of the following features:… | 2000 |
| * | K993907 | Viridia Information Center Software for M3154A Opt C22Summary page 1…Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the addition of the following features: * Su… | 1999 |
| * | K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ASummary page 1…oftware, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the addition of the following features: * Support for… | 1999 |
| * | K964832 | Hewlett-Packard Centralvue SoftwareSummary page 1…ase J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832. 3. The modification made to the device include the addition of the following features: * Support for the Wireless… | 1997 |
| † | K080461 | Star ST and Arrhythmia Software, Release J.0 | 2008 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2012 | Class II | Z-0495-2013 | Component design/selection | Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms. |
| May 3, 2011 | Not classified | Z-2217-2011 | Component design/selection | PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation |
| Dec 17, 2010 | Not classified | Z-0987-2011 | Device Design | Some PAS-201 active speaker assemblies in use with the Philips IntelliVue Information Center (PIIC) have experienced intermittent audio or loss of audio. Speaker failures may delay recognition of an alarm condition, if operators do not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 13 of the 133 ancestors have a recall of any class.
- Of its descendants, K102495 (Philips Medical Systems, 2010) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K062271.
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. 2008, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2007high 21 (2013) · low 5 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
2007high 248 (2014) · low 57 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
2007high 21 (2026) · low 0 (2020)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
2007high 3,761 (2025) · low 131 (2007)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?
Indicated 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081983: M3290A Intellivue Information Center Software, Release 1.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081983
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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