510(k) Report

510(k) · Cleared

Cleared

The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, with 802.11 Wireless Lan

K052961510(k) SpecialCleared Nov 18, 200528-day reviewClass II21 CFR 870.2910

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

Philips Medical Systems · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Nov 18, 2005 as substantially equivalent to K014159 (Philips Medical Systems, Inc., 2002) and 10 other predicates after a 28-day review. Its family tree reaches back 18 generations to 1994. 180 later devices descend from it.

Decided
Nov 18, 2005
Review
28 days
Class
Class II
Product code
DRG
Recalls
None
Predicates
13

Its longest line of descent runs back 18 generations to K941811 (1994). 113 ancestors in all, the oldest K872781 (1987). 180 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 7 other ancestors2002: 9 other ancestors2003: 4 other ancestors2000: 14 other ancestors1999: 8 other ancestors1998: 10 other ancestors1992: 6 other ancestors1991: 5 other ancestors2001: 5 other ancestors1997: 4 other ancestors1996: 4 other ancestors1995: 4 other ancestors1994: 2 other ancestors1993: 5 other ancestors1990: 5 other ancestors1989: 2 other ancestors1987: 1 other ancestor2011: 9 descendants cleared2012: 8 descendants cleared2013: 10 descendants cleared2006: 1 descendant cleared2007: 3 descendants cleared2009: 5 descendants cleared2010: 5 descendants cleared2015: 7 descendants cleared2008: 4 descendants cleared2014: 10 descendants cleared2016: 9 descendants cleared2017: 10 descendants cleared2021: 6 descendants cleared2023: 13 descendants cleared2020: 8 descendants cleared2022: 14 descendants cleared2018: 11 descendants cleared2019: 6 descendants cleared2025: 18 descendants cleared2026: 10 descendants cleared2024: 13 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) ×4: 4 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 17 other ancestors3 generations back: 42 other ancestors4 generations back: 12 other ancestors5 generations back: 8 other ancestors6 generations back: 7 other ancestors7 generations back: 7 other ancestors 1 generation forward: 5 descendants2 generations forward: 26 descendants3 generations forward: 28 descendants4 generations forward: 36 descendants5 generations forward: 32 descendants6 generations forward: 24 descendants7 generations forward: 14 descendants8 generations forward: 9 descendants9 generations forward: 6 descendants K051106 · 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. · 1994−15−10−50+5
  1. Root · 18 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 14 generations between
  3. 3 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  4. 2 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  5. 1 generation backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  6. This deviceK052961 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medical Systems · 2005
  7. Descendant · cites it directly · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
  8. Descendant · 2 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  9. Descendant · 2 generations on · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  10. Descendant · 2 generations on · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
  11. Descendant · 2 generations on · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
Show all 18 generations
  1. Root · 18 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 17 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 16 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 15 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 14 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 13 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 12 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 11 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 10 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 9 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 8 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 7 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 6 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 5 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 4 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 3 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 2 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 1 generation backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. This deviceK052961 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medical Systems · 2005

Showing 5 of 180 descendants. See all descendants

Descendants cleared per year

2006: 12007: 32008: 42009: 52010: 52011: 92012: 82013: 102014: 102015: 72016: 92017: 102018: 112019: 62020: 82021: 62022: 142023: 132024: 132025: 182026: 10
2006high 18 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 180 · See all
  • K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly176descendants
  • K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on175descendants
  • K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on151descendants
  • K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · 2 generations on143descendants
  • K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · 2 generations on127descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−17K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−16K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−15K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−14K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−13K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−12K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−11K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−10K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−9K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−8K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−7K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−6K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−5K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−4K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−3K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−2K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−1K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
0 (this device)K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medical Systems2005—
+1K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006—
+2K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+2K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+2K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue…Philips Medizin Systeme Boeblingen GmbH2008—
+2K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198920
199050
199150
199260
199350
199420
199540
199640
199740
1998100
199980
2000140
200150
200290
200340
200470

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200730
200840
200950
201050
201190
201280
2013100
2014100
201570
201690
2017100
2018110
201960
202080
202160
2022140
2023130
2024130
2025180
2026100
FIG. 1 — Lineage of K052961, 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.

Planning a device in DRG? 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 DRG device

  1. #1 K223711 ANNE Onescore 20.8 · 11 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? (13)

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
*K014159Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor
Summary page 2
…troencephalograph (12520) Neurological (12513) 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4.…
Philips Medical Systems, Inc.2002—
*K021778Philips Component Compact Monitor, Release a.04, Model #M1275B
Summary page 2
…alograph (12520) Neurological (12513) 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The mod…
Philips Medical Systems2002—
*K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…
Summary page 2
…2520) Neurological (12513) 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a…
Philips Medical Systems, Inc.2003—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 2
…rological (12513) 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change t…
Philips Medizin Systeme Boblingen GmbH2003—
*K040304Philips Intellivue Patient Monitor, Models MP40 & MP50
Summary page 2
…(12513) 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creat…
Philips Medizin Systeme Boeblingen GmbH2004—
Kept off the family treeK040183FDA’s K040183 is BISX
Our reading of the summary gave K040183, FDA’s number for BISX (Aspect Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips devices”. Kept off the family tree.
Summary page 2
…3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an op…
Aspect Medical Systems, Inc.2004—
*K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…
Summary page 2
…dified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an optional, 802.…
Philips Medical Systems, Inc.2004—
*K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…vices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an optional, 802.11 w…
Philips Medizin Systeme Boeblingen GmbH2004—
Kept off the family treeK041741FDA’s K041741 is M3290A Intellivue Information Center Software Release F.0 and M4840A Philips…
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Philips Medical Systems, Inc.20044
*K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors
Summary page 2
…y equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an optional, 802.11 wireless network adapte…
Philips Medizin Systeme Boblingen GmbH2004—
*K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…ent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an optional, 802.11 wireless network adapter for the…
Philips Medizin Systeme Boeblingen GmbH2005—
*K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90
Summary page 2
…eviously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an optional, 802.11 wireless network adapter for the Philips…
Philips Medizin Systeme Boeblingen GmbH2005—
*K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors
Summary page 2
…cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106. 4. The modification is a change that creates, an optional, 802.11 wireless network adapter for the Philips MPxx IntelliV…
Philips Medizin Systeme Boeblingen GmbH2005—

Also cleared against K014159: 9 other devices →

What descends from it? (180)

See all 180

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

NumberDeviceApplicantDecidedDescendants
K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176
K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246
K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201337
K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201337
K110809Wireless Monitoring SystemCarefusion 303, Inc.20112

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 11 years and passes through 6 companies; a new generation was cleared every 4 months on median.
  • 4 of the 113 ancestors have a recall of any class.
  • Of its descendants, K062392 (Philips Medizin Systeme Boeblingen GmbH, 2006) has gone furthest, with 176 descendants of its own.
  • 9 other devices also cite its predicate K014159.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

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

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

What is it indicated for?

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare environments.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K052961: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, with 802.11 Wireless Lan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052961

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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