510(k) · Cleared
ClearedM3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology
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 Dec 4, 2002 as substantially equivalent to K013427 (Philips Medical Systems, Inc., 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 8 generations to 1994. 406 later devices descend from it.
- Decided
- Dec 4, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K941811 (1994). 49 ancestors in all, the oldest K872781 (1987). 406 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 3 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 2 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 1 generation backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- This deviceK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 312 of its ownK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- Descendant · 2 generations on · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
Showing 5 of 406 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 406 · See all- K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · cites it directly404descendants
- 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
- K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004 · 3 generations on312descendants
- K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc. · 2004 · 2 generations on260descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −3 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −2 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −1 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| 0 (this device) | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| +1 | 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 | — |
| +3 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| +2 | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A… | Philips Medical Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 14 | 0 |
| 2007 | 6 | 0 |
| 2008 | 14 | 0 |
| 2009 | 15 | 0 |
| 2010 | 20 | 0 |
| 2011 | 19 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 14 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 17 | 0 |
| 2018 | 25 | 0 |
| 2019 | 17 | 0 |
| 2020 | 14 | 0 |
| 2021 | 18 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 19 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013427 | Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips… | 2001 |
| * | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275BSummary page 2…Electroencephalogram Signal 3. The new devices are substantially equivalent to previously cleared Philips devices marketed pursuant to KO13427 and K021778. 4. The modification is primarily a software-based change that incorporates a Data Export function communication protocol to… | 2002 |
What descends from it? (406)
See all 4067 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185… | 2003 | 404 |
| K110622 | Intellivue Patient Monitor | 2011 | 90 |
| K113657 | Intellivue Patient Monitor | 2012 | 81 |
| K113441 | Physiological Monitor, Patient Monitor | 2012 | 78 |
| K120366 | Intellivue Patient Monitor | 2012 | 46 |
| K122439 | Intellivue Patient Monitor | 2012 | 41 |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P… | 2005 | 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 8 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 2 of the 49 ancestors have a recall of any class.
- Of its descendants, K030038 (Philips Medical Systems, Inc., 2003) has gone furthest, with 404 descendants of its own.
- 1 other device also cites its predicate K013427.
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 monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates, in hospital and/or medical transport environments.
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023871: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023871
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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