510(k) · Cleared
ClearedM3290A Intellivue Information Center Software Release G.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 Apr 5, 2005 as substantially equivalent to K031403 (Philips Medical Systems, Inc., 2003) after a 14-day review. Its family tree reaches back 2 generations to 2001. 16 later devices descend from it.
- Decided
- Apr 5, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011093 (2001). 16 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
- 1 generation backK031403 M3290A Intellivue Information Center Software Release E.1Philips Medical Systems, Inc. · 2003
- This deviceK050742 M3290A Intellivue Information Center Software Release G.00Philips Medical Systems · 2005
- 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 · cites it directly · 4 of its ownK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · 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
- K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154 | Agilent Technologies, Inc. | 2001 | 4 |
| −1 | K031403 | M3290A Intellivue Information Center Software Release E.1 | Philips Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K050742 | M3290A Intellivue Information Center Software Release G.00 | Philips Medical Systems | 2005 | — |
| +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 |
| +1 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | E011093 | IntelliVue Information Center Software Number could not be read Summary page 1…Physiological Monitors 3. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under E011093 and K031403. 4. The modification is a change that provides different alert data export via the hospital LAN. 5. The new d… | |
| * | K031403 | M3290A Intellivue Information Center Software Release E.1Summary page 1…Physiological Monitors 3. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under E011093 and K031403. 4. The modification is a change that provides different alert data export via the hospital LAN. 5. The new device has the s… | 2003 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K100420 | Philips Obtracevue Model SW Rev. G.00 | 2010 | 4 |
| K122146 | Xhibit Central Station, Model 96102 | 2013 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K062271 (Philips Medical Systems, 2006) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K031403.
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?
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/K050742 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050742: M3290A Intellivue Information Center Software Release G.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050742
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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