510(k) Report

510(k) · Cleared

Cleared

Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B

K013199510(k) SpecialCleared Nov 28, 200164-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2000: 7 other ancestors1999: 3 other ancestors1998: 2 other ancestors1993: 2 other ancestors1992: 3 other ancestors1990: 2 other ancestors1989: 1 other ancestor1997: 2 other ancestors1995: 2 other ancestors1987: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor2003: 5 descendants cleared2002: 4 descendants cleared2006: 16 descendants cleared2010: 21 descendants cleared2011: 21 descendants cleared2005: 10 descendants cleared2008: 14 descendants cleared2004: 10 descendants cleared2007: 7 descendants cleared2009: 19 descendants cleared2012: 19 descendants cleared2014: 16 descendants cleared2013: 17 descendants cleared2015: 14 descendants cleared2017: 17 descendants cleared2016: 17 descendants cleared2018: 25 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2020: 14 descendants cleared2023: 27 descendants cleared2019: 17 descendants cleared2024: 25 descendants clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 55 descendants3 generations forward: 54 descendants4 generations forward: 70 descendants5 generations forward: 72 descendants6 generations forward: 70 descendants7 generations forward: 43 descendants8 generations forward: 22 descendants9 generations forward: 24 descendants10 generations forward: 13 descendants11 generations forward: 1 descendant K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−50+5+10
  1. Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 1 generation backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. This deviceK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. Descendant · cites it directly · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  8. Descendant · cites it directly · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  9. Descendant · cites it directly · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  10. Descendant · 2 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  11. 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

2002: 42003: 52004: 102005: 102006: 162007: 72008: 142009: 192010: 212011: 212012: 192013: 172014: 162015: 142016: 172017: 172018: 252019: 172020: 142021: 192022: 282023: 272024: 252025: 292026: 20
2002high 29 (2025) · low 4 (2002)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−5K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−4K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−3K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−2K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−1K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
0 (this device)K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+1K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+1K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
+1K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+2K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
+2K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199020
199230
199320
199410
199520
199610
199720
199820
199930
200070

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200350
2004100
2005100
2006160
200770
2008140
2009190
2010210
2011210
2012190
2013170
2014160
2015140
2016170
2017170
2018250
2019170
2020140
2021190
2022280
2023270
2024250
2025290
2026200
FIG. 1 — Lineage of K013199, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K971910Multi-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…
Hewlett-Packard GmbH1998—
*K981576Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A
Summary 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…
Hewlett-Packard GmbH1998—
*K990972HP 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…
Hewlett-Packard GmbH1999—
*K991773HP 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…
Hewlett-Packard GmbH1999—
*K992273HP 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…
Hewlett-Packard GmbH2000—
*K993383HP 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…
Hewlett-Packard GmbH20002
*K000822Agilentcomponent 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,…
Agilent Technologies, GmbH2000—
*K001057Agilent 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,…
Agilent Technologies, Inc.2000—
*K001333Agilent 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,…
Agilent Technologies Deutschland GmbH2000—
*K003621ST/AR ST and Arrhythmia Software, Model Release D.0
Summary 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…
Agilent Technologies, Inc.2000—
*K882609Models M1175A & M1176A Component Monitoring System
Summary 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…
Waltham Div. Hewlett Packard1989—
*K900032Model M1175A/M1176A with ST Segment Monitoring
Summary 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…
Hewlett-Packard Co.1990—
*K922058Models M1175A and M1176A Component Monitoring Syst
Summary 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…
Hewlett-Packard Co.1992—
*K923682Model M1032A Vuelink Interface Plug-in Module
Summary 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…
Hewlett-Packard Co.1992—
*K925910Hewlett-Packard Model M1018A TCPO2/TOPCO2 Module
Summary 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…
Hewlett-Packard Co.1993—
*K941811HP M1175A, M1176A, Component Monitoring System
Summary 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…
Hewlett-Packard Co.1994—
*K990125HP Viridia Component Monitoring System, Model Rev. K
Summary 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…
Hewlett-Packard GmbH1999—
*K990476HP 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,…
Hewlett-Packard GmbH1999—
*K992595HP 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…
Hewlett-Packard GmbH1999—
*K001722Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module
Summary 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…
Agilent Technologies Deutschland GmbH2000—

Also cleared against K971910: 11 other devices →

What descends from it? (431)

See all 431

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002421
K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems2002416
K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002407
K030973Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems2003198
K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123
K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201184
K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638

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 devices

MHX 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

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

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.

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