510(k) · Cleared
ClearedM3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical Network on Vlan
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 May 12, 2004 as substantially equivalent to K993171 (Hewlett-Packard Co., 1999) and 9 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1994. 10 later devices descend from it.
- Decided
- May 12, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 11 generations to K941811 (1994). 65 ancestors in all, the oldest K872781 (1987). 10 later devices descend from it, 3 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 deviceK040955 M3290A Intellivue Information Center Software Release E.01 and…Philips Medical Systems, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK062271 M3290A Intellivue Information Center Software, Release J.00 (for…Philips Medical Systems · 2006 · Recalled
- Descendant · cites it directly · 8 of its ownK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · Recalled
- 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
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 deviceK040955 M3290A Intellivue Information Center Software Release E.01 and…Philips Medical Systems, Inc. · 2004
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
2006high 2 (2016) · low 0 (2007)2026
Most influential descendants
Showing 5 of 10 · See all- K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems · 2006 · cites it directly9descendants
- K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · cites it directly8descendants
- 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
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) | K040955 | M3290A Intellivue Information Center Software Release E.01 and Intellivue… | Philips Medical Systems, Inc. | 2004 | — |
| +1 | K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145… | Philips Medical Systems | 2006 | 3 |
| +1 | K081983 | M3290A Intellivue Information Center Software, Release 1.00 | Philips Medical Systems | 2008 | 3 |
| +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 |
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 | 5 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (10)
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 |
|---|---|---|---|
| * | K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ASummary page 1…itors 3. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that perm… | 1999 |
| * | K993907 | Viridia Information Center Software for M3154A Opt C22Summary page 1…The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits opera… | 1999 |
| * | K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…Summary page 1…device is substantially equivalent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of t… | 2000 |
| * | K001664 | Compact Portable Patient Monitor with Wireless Alan, Model Alilent M3000A/M3046A Option…Summary page 1…substantially equivalent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the Int… | 2000 |
| * | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154Summary page 1…ially equivalent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the IntelliVue C… | 2001 |
| * | K021422 | Philips Information Center Software Revision D.02Summary page 1…lent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the IntelliVue Clinical Netw… | 2002 |
| * | K023698 | M3290A Intellivue Information Center Software Release E.OSummary page 1…he previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the IntelliVue Clinical Network on cu… | 2002 |
| * | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Summary page 1…usly cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the IntelliVue Clinical Network on customer pr… | 2003 |
| * | K031403 | M3290A Intellivue Information Center Software Release E.1Summary page 1…red IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IE… | 2003 |
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 1…lliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357. 4. The modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IEEE 802.1q… | 2004 |
What descends from it? (10)
3 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)
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 10 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 3 of the 65 ancestors have a recall of any class.
- Of its descendants, K062271 (Philips Medical Systems, 2006) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K993171.
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
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/K040955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040955: M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical Network on Vlan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040955
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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