510(k) · Cleared
ClearedPhilips Information Center Software Revision D.02
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 May 15, 2002 as substantially equivalent to K964832 (Hewlett-Packard Co., 1997) and 4 other predicates after a 12-day review. Its family tree reaches back 3 generations to 1997. 426 later devices descend from it.
- Decided
- May 15, 2002
- Review
- 12 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K964832 (1997). 5 ancestors in all. 426 later devices descend from it, 6 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 deviceK021422 Philips Information Center Software Revision D.02Philips Medical Systems · 2002
- Descendant · cites it directly · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- Descendant · 2 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- Descendant · 2 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- Descendant · 2 generations on · 375 of its ownK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
Showing 5 of 426 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 426 · See all- K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · cites it directly407descendants
- K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 2 generations on406descendants
- K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 2 generations on404descendants
- K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 2 generations on376descendants
- K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH · 2003 · 2 generations on375descendants
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) | K021422 | Philips Information Center Software Revision D.02 | Philips Medical Systems | 2002 | — |
| +1 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| +2 | 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 | — |
| +2 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| +2 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 15 | 0 |
| 2007 | 7 | 0 |
| 2008 | 15 | 0 |
| 2009 | 15 | 0 |
| 2010 | 21 | 0 |
| 2011 | 19 | 0 |
| 2012 | 20 | 0 |
| 2013 | 17 | 0 |
| 2014 | 16 | 0 |
| 2015 | 15 | 0 |
| 2016 | 16 | 0 |
| 2017 | 19 | 0 |
| 2018 | 26 | 0 |
| 2019 | 17 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 25 | 0 |
| 2025 | 28 | 0 |
| 2026 | 21 | 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? (5)
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 |
|---|---|---|---|
| * | K964832 | Hewlett-Packard Centralvue SoftwareSummary page 1…and Communication, Physioclogical Monitors - 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093. 4. The modification is a software-based change that adds tabular trends to the trend re… | 1997 |
| * | K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ASummary page 1…unication, Physioclogical Monitors - 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093. 4. The modification is a software-based change that adds tabular trends to the trend review capa… | 1999 |
| * | K993907 | Viridia Information Center Software for M3154A Opt C22Summary page 1…, Physioclogical Monitors - 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093. 4. The modification is a software-based change that adds tabular trends to the trend review capability an… | 1999 |
| * | K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…Summary page 1…logical Monitors - 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093. 4. The modification is a software-based change that adds tabular trends to the trend review capability and permits… | 2000 |
| * | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154Summary page 1…ors - 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093. 4. The modification is a software-based change that adds tabular trends to the trend review capability and permits ICA compatib… | 2001 |
What descends from it? (426)
See all 4266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | 2002 | 407 |
| K023674 | Philips Drug Calculator Software | 2002 | 17 |
| 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)
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 5 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K021778 (Philips Medical Systems, 2002) has gone furthest, with 407 descendants of its own.
- 5 other devices also cite its predicate K964832.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021422: Philips Information Center Software Revision D.02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021422
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