510(k) · Cleared
Recalled · 2008M3290A Intellivue Information Center Software Release E.O
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 Nov 19, 2002 as substantially equivalent to K993907 (Agilent Technologies, Inc., 1999) after a 15-day review. Its family tree reaches back 3 generations to 1997. 11 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964832 (1997). 11 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK964832 Hewlett-Packard Centralvue SoftwareHewlett-Packard Co. · 1997
- 2 generations backK993171 HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154AHewlett-Packard Co. · 1999
- 1 generation backK993907 Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 1999
- This deviceK023698 M3290A Intellivue Information Center Software Release E.OPhilips Medical Systems · 2002
- Descendant · cites it directly · 10 of its ownK040955 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc. · 2004 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964832 | Hewlett-Packard Centralvue Software | Hewlett-Packard Co. | 1997 | — |
| −2 | K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154A | Hewlett-Packard Co. | 1999 | — |
| −1 | K993907 | Viridia Information Center Software for M3154A Opt C22 | Agilent Technologies, Inc. | 1999 | — |
| 0 (this device) | K023698 | M3290A Intellivue Information Center Software Release E.O | Philips Medical Systems | 2002 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K993907 | Viridia Information Center Software for M3154A Opt C22Summary page 1…ological Monitors 3. The new device is substantially equivalent to the previously cleared VIC Web software cleared under K993907. 4 . The modification is a software-based change that provides improved database server access via the hospital intr… | 1999 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040955 | M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical… | 2004 | 10 |
| 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 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2008 | Not classified | Z-0034-2011 | Component change control | Potential for Internal Sound Amplifier to malfunction which could delay treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040955 (Philips Medical Systems, Inc., 2004) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K993907.
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?
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/K023698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023698: M3290A Intellivue Information Center Software Release E.O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023698
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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