510(k) · Cleared
ClearedPhilips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B
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 Nov 28, 2001 as substantially equivalent to K971910 (Hewlett-Packard GmbH, 1998) and 19 other predicates after a 64-day review. Its family tree reaches back 5 generations to 1994. 431 later devices descend from it.
- Decided
- Nov 28, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 20
Its longest line of descent runs back 5 generations to K941811 (1994). 32 ancestors in all, the oldest K872781 (1987). 431 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- This deviceK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- Descendant · cites it directly · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- Descendant · cites it directly · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips 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
Showing 5 of 431 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 431 · See all- K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · cites it directly421descendants
- K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · cites it directly416descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| +1 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| +1 | 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 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 10 | 0 |
| 2006 | 16 | 0 |
| 2007 | 7 | 0 |
| 2008 | 14 | 0 |
| 2009 | 19 | 0 |
| 2010 | 21 | 0 |
| 2011 | 21 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 16 | 0 |
| 2015 | 14 | 0 |
| 2016 | 17 | 0 |
| 2017 | 17 | 0 |
| 2018 | 25 | 0 |
| 2019 | 17 | 0 |
| 2020 | 14 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 27 | 0 |
| 2024 | 25 | 0 |
| 2025 | 29 | 0 |
| 2026 | 20 | 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? (20)
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 |
|---|---|---|---|
| * | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A)Summary page 2…Thermometer, electronic, General clinical Hospital The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K8826… | 1998 |
| * | K981576 | Multi-Parameter Module, Model M3000A & Display Unit, Model M3046ASummary page 2…ter, electronic, General clinical Hospital The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K9000… | 1998 |
| * | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 2…c, General clinical Hospital The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K… | 1999 |
| * | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 2…l clinical Hospital The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K… | 1999 |
| * | K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Summary page 2…l Hospital The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K… | 2000 |
| * | K993383 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…Summary page 2…l The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K… | 2000 |
| * | K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…Summary page 2…w device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125,… | 2000 |
| * | K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…Summary page 2…is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476,… | 2000 |
| * | K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…Summary page 2…ntially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595,… | 2000 |
| * | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0Summary page 2…alent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The… | 2000 |
| * | K882609 | Models M1175A & M1176A Component Monitoring SystemSummary page 2…46/3000A) device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a… | 1989 |
| * | K900032 | Model M1175A/M1176A with ST Segment MonitoringSummary page 2…device marketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified… | 1990 |
| * | K922058 | Models M1175A and M1176A Component Monitoring SystSummary page 2…arketed pursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. Th… | 1992 |
| * | K923682 | Model M1032A Vuelink Interface Plug-in ModuleSummary page 2…ursuant to K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new dev… | 1992 |
| * | K925910 | Hewlett-Packard Model M1018A TCPO2/TOPCO2 ModuleSummary page 2…o K971910, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new device has t… | 1993 |
| * | K941811 | HP M1175A, M1176A, Component Monitoring SystemSummary page 2…, K981576 , and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new device has the same I… | 1994 |
| * | K990125 | HP Viridia Component Monitoring System, Model Rev. KSummary page 2…, and K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new device has the same Indication… | 1999 |
| * | K990476 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg…Summary page 2…0972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new device has the same Indications for Use,… | 1999 |
| * | K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…Summary page 2…1773, K992273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new device has the same Indications for Use, for use… | 1999 |
| * | K001722 | Agilent Component Monitoring System; Agilent Invasive Blood Pressure ModuleSummary page 2…2273, K993383, K000822, K001057, K001333, and K003621, as well as M1175/76A pursuant to K882609, K900032, K922058, K923682, K925910, K941811, K990125, K990476, K992595, K001722. The modification is a new display unit and a modified rack. The new device has the same Indications for Use, for use by health… | 2000 |
What descends from it? (431)
See all 4317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | 2002 | 421 |
| K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release… | 2002 | 416 |
| K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | 2002 | 407 |
| K030973 | Picosat II SPO2 Pulse Oximetry Module | 2003 | 198 |
| K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70… | 2010 | 123 |
| K110474 | Philips Intellivue TCG10 | 2011 | 84 |
| K062268 | Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03 | 2006 | 38 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 32 ancestors has a recall of any class.
- Of its descendants, K021300 (Philips Medical Systems, 2002) has gone furthest, with 421 descendants of its own.
- 11 other devices also cite its predicate K971910.
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 use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
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/K013199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013199
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026