510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Philips Intellivue TCG10

K110474510(k) AbbreviatedCleared Sep 30, 2011224-day reviewClass II21 CFR 868.2480Recalls 1

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

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · LKD Monitor, Carbon-Dioxide, Cutaneous

Cleared on Sep 30, 2011 as substantially equivalent to K013199 (Philips Medical Systems, Inc., 2001) and 15 other predicates after a 224-day review. Its family tree reaches back 30 generations to 1994. 84 later devices descend from it. It has been recalled once.

Decided
Sep 30, 2011
Review
224 days
Class
Class II
Product code
LKD
Recalls
1
Predicates
17

Its longest line of descent runs back 30 generations to K941811 (1994). 192 ancestors in all, the oldest K844187 (1985). 84 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 3 other ancestors2009: 1 other ancestor2008: 2 other ancestors2006: 5 other ancestors2007: 3 other ancestors2005: 4 other ancestors2004: 14 other ancestors2003: 12 other ancestors2002: 14 other ancestors2001: 9 other ancestors2000: 19 other ancestors1999: 10 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 10 other ancestors1993: 5 other ancestors1992: 6 other ancestors1990: 6 other ancestors1989: 3 other ancestors1995: 6 other ancestors1994: 2 other ancestors1991: 6 other ancestors1987: 1 other ancestor1985: 1 other ancestor2012: 3 descendants cleared2014: 3 descendants cleared2013: 5 descendants cleared2015: 3 descendants cleared2017: 5 descendants cleared2016: 2 descendants cleared2023: 10 descendants cleared2020: 5 descendants cleared2022: 7 descendants cleared2018: 7 descendants cleared2019: 6 descendants cleared2021: 3 descendants cleared2025: 12 descendants cleared2024: 7 descendants cleared2026: 6 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) ×9: 9 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004) ×11: 11 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K061610 (2006), K063315 (2006) K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009×2: 2 generations cleared close together, K100939 (2010), K101449 (2010) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 41 other ancestors3 generations back: 33 other ancestors4 generations back: 38 other ancestors5 generations back: 16 other ancestors6 generations back: 15 other ancestors7 generations back: 11 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 7 descendants3 generations forward: 18 descendants4 generations forward: 13 descendants5 generations forward: 12 descendants6 generations forward: 7 descendants7 generations forward: 8 descendants8 generations forward: 5 descendants9 generations forward: 6 descendants K101449 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · 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. · 1994−30−25−20−15−10−50+5
  1. Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 26 generations between
  3. 3 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  4. 2 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  5. 1 generation backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  6. This deviceK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  7. Descendant · cites it directly · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled
  8. Descendant · cites it directly · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
  9. Descendant · cites it directly · 41 of its ownK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
  10. Descendant · cites it directly · 37 of its ownK131872 Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  11. Descendant · 2 generations on · 37 of its ownK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
Show all 30 generations
  1. Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 29 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 28 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 27 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 26 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 25 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 24 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 23 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 22 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 21 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 20 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 19 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 18 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 17 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 16 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 15 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 14 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 13 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 12 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 11 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 10 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 9 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 8 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 7 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 6 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 5 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 4 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 3 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 2 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. 1 generation backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  31. This deviceK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2012: 32013: 52014: 32015: 32016: 22017: 52018: 72019: 62020: 52021: 32022: 72023: 102024: 72025: 122026: 6
2012high 12 (2025) · low 2 (2016)2026

Most influential descendants

Showing 5 of 84 · See all
  • K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · cites it directly78descendants
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · cites it directly46descendants
  • K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · cites it directly41descendants
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · cites it directly37descendants
  • K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · 2 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−30K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−29K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−28K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−27K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−26K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−25K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−24K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−23K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−22K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−21K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−20K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−19K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−18K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−17K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−16K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−15K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−14K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−13K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−12K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−11K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−10K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−9K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−8K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−7K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−6K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−5K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−4K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−3K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
−2K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−1K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
0 (this device)K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
+1K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20121
+1K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012—
+1K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH20124
+1K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20135
+2K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20138

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198930
199060
199160
199260
199350
199420
199560
1996100
199770
1998130
1999100
2000190
200190
2002140
2003120
2004140
200540
200650
200730
200820
200910
201030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201350
201430
201530
201620
201750
201870
201960
202050
202130
202270
2023100
202470
2025120
202660
FIG. 1 — Lineage of K110474, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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  1. #1 K232516 Sentec Digital Monitoring System (SDMS) tCOM+score 10.1 · 10 generations · no Class I recall
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What was it cleared against? (17)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B
Summary page 2
…PSO, MP9O, and MX800 IntelliVue Patient Monitors are substantially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [1014…
Philips Medical Systems, Inc.2001—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 2
…, and MX800 IntelliVue Patient Monitors are substantially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K…
Philips Medizin Systeme Boblingen GmbH2003—
*K040304Philips Intellivue Patient Monitor, Models MP40 & MP50
Summary page 2
…00 IntelliVue Patient Monitors are substantially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562.…
Philips Medizin Systeme Boeblingen GmbH2004—
*K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…lliVue Patient Monitors are substantially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modif…
Philips Medizin Systeme Boeblingen GmbH2004—
*K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90
Summary page 2
…ent Monitors are substantially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philip…
Philips Medizin Systeme Boeblingen GmbH2005—
*K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00
Summary page 2
…ors are substantially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliB…
Philips Medizin Systeme Boeblingen GmbH2006—
*K062392Philips MP5 Intellivue Patient Monitor
Summary page 2
…antially equivalent to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 an…
Philips Medizin Systeme Boeblingen GmbH2006—
Kept off the family treeK071426FDA’s K071426 is MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
*K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…
Summary page 2
…to the previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules ar…
Philips Medizin Systeme Boeblingen GmbH2008—
*K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…
Summary page 2
…previously cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules are substa…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083
*K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…
Summary page 2
…y cleared Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules are substantially…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
*K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90
Summary page 2
…Philips intelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules are substantially equivalent…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
*K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…
Summary page 2
…telliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules are substantially equivalent to th…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
*K101449Intellivue Patient Monitor
Summary page 2
…ent Monitors marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules are substantially equivalent to the previous…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
*K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…
Summary page 2
…marketed pursuant to K013199, K032858, K040304, [K041235, [(050762, [K053522, [K062392, [K71426, [K081793, [K082633, [K083517, [K091927, [K100939, [101449 and [K102562. The modified Philips IntelliBridge EC10 and EC5 ID modules are substantially equivalent to the previously cleared…
Philips Medizin Systeme Boblingen GmbH2010—
*K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…
Our OCR of the scanned summary read K082483, FDA’s number for Quantra (Hologic, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Philips IntelliBridge EC10 and EC5 ID modules”.
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20095
*K093154TCM Tosca Monitoring System, TCM Combim Monitoring System
Summary page 2
…new Philips IntelliVue TcGl0 Measurement Module is substantially equivalent to the previously cleared TCM CombiM Monitoring System marketed pursuant to [(093154 and in particular to the TCM CombiM Measurement Module which is the measurement unit of the TCM CombiM Monitoring System. 4.…
Radiometer Medical Aps20103

Also cleared against K013199: 6 other devices →

What descends from it? (84)

See all 84

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

NumberDeviceApplicantDecidedDescendants
K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201278
K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246
K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH201241
K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201337
K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201436
K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH201534
K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH201532
K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2014Class IIZ-0997-2015Under Investigation by firmPhilips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 8 companies; a new generation was cleared every 4 months on median.
  • 29 of the 192 ancestors have a recall of any class.
  • Of its descendants, K113441 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2012) has gone furthest, with 78 descendants of its own.
  • 6 other devices also cite its predicate K013199.

How does its category compare?

All LKD devices

LKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LKD

1in 2024

2010: 22011: 12013: 12015: 12024: 1
2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKD

Too few LKD 510(k)s in any year since 2007 to give a median.

Recalls per year · LKD

1in 2022

2009: 42011: 12012: 22014: 12016: 12022: 1
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LKD

3in 2025

2010: 82012: 42013: 12014: 212015: 202016: 42019: 32020: 62021: 22023: 12024: 12025: 3
2007high 21 (2014) · low 0 (2007)2025

MAUDE reports naming product code LKD, 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
20070—00
20080—00
20090—40
20102—08
20111—10
20120—24
20131—01
20140—121
20151—020
20160—14
20170—00
20180—00
20190—03
20200—06
20210—02
20220—10
20230—01
20241—01
20250—03
20260—0—

What is it indicated for?

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K013199

6 other devices cite the same predicate.

  • K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  • K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co. · 2006
  • K030973Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275BPhilips Medical Systems · 2002

More from Philips Medizinsysteme Boeblingen…

25 FDA decisions under this applicant name. See the company

  • K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20141 recall
  • K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20135 recalls
  • K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013
  • K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20138 recalls

Recent decisions in LKD

The LKD category page

  • K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
  • K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including…Sentec AG · 20159 recalls
  • K131253Periflux 6000Perimed AB · 2013
  • K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 201012 recalls
  • K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 20103 recalls

https://510kreport.com/device/K110474 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110474: Philips Intellivue TCG10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110474

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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