510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

M3290B Intellivue Information Center Software, Release a.0

K102495510(k) SpecialCleared Sep 30, 201030-day reviewClass II21 CFR 870.1025Recalls 7

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

Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Sep 30, 2010 as substantially equivalent to K081983 (Philips Medical Systems, 2008) and 14 other predicates after a 30-day review. Its family tree reaches back 22 generations to 1994. 7 later devices descend from it. It has been recalled 7 times.

Decided
Sep 30, 2010
Review
30 days
Class
Class II
Product code
MHX
Recalls
7
Predicates
15

Its longest line of descent runs back 22 generations to K941811 (1994). 134 ancestors in all, the oldest K872781 (1987). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 9 other ancestors2003: 5 other ancestors2002: 10 other ancestors2001: 5 other ancestors2000: 17 other ancestors1999: 9 other ancestors1997: 6 other ancestors1998: 13 other ancestors1996: 6 other ancestors1995: 4 other ancestors1993: 5 other ancestors1991: 6 other ancestors1989: 2 other ancestors1992: 6 other ancestors1990: 5 other ancestors1994: 2 other ancestors1987: 1 other ancestor2013: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant 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) ×6: 6 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006) K062271 · M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) · Philips Medical Systems · 2006 · recalledK081983 · M3290A Intellivue Information Center Software, Release 1.00 · Philips Medical Systems · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 13 other ancestors2 generations back: 4 other ancestors3 generations back: 21 other ancestors4 generations back: 24 other ancestors5 generations back: 19 other ancestors6 generations back: 9 other ancestors7 generations back: 11 other ancestors8 generations back: 6 other ancestors9 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K081983 · M3290A Intellivue Information Center Software, Release 1.00 · Philips Medical Systems · 2008 · recalledK062271 · M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) · Philips Medical Systems · 2006 · recalledK053522 · 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. · 1994−20−15−10−50
  1. Root · 22 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 18 generations between
  3. 3 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK062271 M3290A Intellivue Information Center Software, Release J.00 (for…Philips Medical Systems · 2006 · Recalled
  5. 1 generation backK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · Recalled
  6. This deviceK102495 M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010
  7. Descendant · cites it directly · 4 of its ownK143057 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK153702 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016 · Recalled
  9. Descendant · 3 generations on · 2 of its ownK163584 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017
  10. Descendant · cites it directly · 1 of its ownK131032 Philips Suresigns CentralPhilips Medical Systems · 2013
  11. Descendant · 4 generations on · 0 of its ownK183387 M3290B Patient Information Center iXPhilips Medical Systems · 2019
Show all 22 generations
  1. Root · 22 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 21 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 20 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 19 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 18 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 17 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 16 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 15 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 14 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 13 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 12 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 11 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 10 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 9 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 8 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 7 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 6 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 5 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 4 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 3 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 2 generations backK062271 M3290A Intellivue Information Center Software, Release J.00 (for…Philips Medical Systems · 2006 · Recalled
  22. 1 generation backK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · Recalled
  23. This deviceK102495 M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12016: 22017: 12018: 12019: 1
2013high 2 (2016) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · cites it directly4descendants
  • K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016 · 2 generations on3descendants
  • K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017 · 3 generations on2descendants
  • K131032Philips Suresigns CentralPhilips Medical Systems · 2013 · cites it directly1descendant
  • K183387M3290B Patient Information Center iXPhilips Medical Systems · 2019 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−21K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−20K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−19K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−18K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−17K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−16K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−15K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−14K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−13K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−12K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−11K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−10K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−9K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−8K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−7K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−6K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−5K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−4K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−3K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−2K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145…Philips Medical Systems20063
−1K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems20083
0 (this device)K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems2010—
+1K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20141
+2K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201612
+3K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2017—
+1K131032Philips Suresigns CentralPhilips Medical Systems2013—
+4K183387M3290B Patient Information Center iXPhilips Medical Systems2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198920
199050
199160
199260
199350
199420
199540
199660
199760
1998130
199990
2000170
200150
2002100
200350
200490
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201620
201710
201810
201910
FIG. 1 — Lineage of K102495, 1994–2019Source: 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? (15)

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
*K081983M3290A Intellivue Information Center Software, Release 1.00
Summary page 1
…tion Center (IIC) is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171,…
Philips Medical Systems20083
*K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…
Summary page 1
…ter (IIC) is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and…
Philips Medical Systems20063
*K050742M3290A Intellivue Information Center Software Release G.00
Summary page 1
…is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K9648…
Philips Medical Systems2005—
*K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…
Summary page 1
…antially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The…
Philips Medical Systems, Inc.20044
*K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…
Summary page 1
…equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVu…
Philips Medical Systems, Inc.2004—
*K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…
Summary page 1
…to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Informat…
Philips Medical Systems, Inc.2004—
*K031403M3290A Intellivue Information Center Software Release E.1
Summary page 1
…reviously cleared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Softwa…
Philips Medical Systems, Inc.2003—
*K023698M3290A Intellivue Information Center Software Release E.O
Summary page 1
…leared M3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is cent…
Philips Medical Systems20021
*K021422Philips Information Center Software Revision D.02
Summary page 1
…3290A IntelliVue Information Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is central stati…
Philips Medical Systems2002—
*K011093Agilent Information Center Software for M3150,M3151,M3153 and M3154
Our reading of the summary gave K001093, FDA’s number for Candela SPTL-1B Pulsed Dye Laser (Candela Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “M3290A IntelliVue Information Center Software, Release L.0”.
Agilent Technologies, Inc.20014
*K001057Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…
Summary page 1
…formation Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is central station software that ru…
Agilent Technologies, Inc.2000—
*K000854Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry System…
Summary page 1
…Center Software, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is central station software that runs on off…
Agilent Technologies, Inc.2000—
*K993907Viridia Information Center Software for M3154A Opt C22
Summary page 1
…oftware, Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is central station software that runs on off-the-shel…
Agilent Technologies, Inc.1999—
*K993171HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154A
Summary page 1
…Release L.0 marketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is central station software that runs on off-the-shelf Windows…
Hewlett-Packard Co.1999—
*K964832Hewlett-Packard Centralvue Software
Summary page 1
…rketed pursuant to K(081983, K062271, K050742, K041741, K040955, 1(040357, K031403, K(023698, K021422, KO011093, K001057, K000854, K993907, K993 171, and K964832. The IntelliVue Information Center Software is central station software that runs on off-the-shelf Windows PCs and servers which…
Hewlett-Packard Co.1997—

Also cleared against K081983: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20144
K131032Philips Suresigns CentralPhilips Medical Systems20131

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 3, 2018Class IIZ-0776-2018Software designOnce a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart…
Nov 25, 2015Class IIZ-0856-2016Software Design ChangeReconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Nov 25, 2015Class IIZ-0857-2016Software Design ChangeReconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Nov 25, 2015Class IIZ-0858-2016Software Design ChangeReconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Dec 19, 2014Class IIZ-0374-2016Software Design ChangeSp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Mar 5, 2013Class IIZ-1783-2014Software designIf a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that…
Nov 9, 2012Class IIZ-0495-2013Component design/selectionInternal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 4 months on median.
  • 14 of the 134 ancestors have a recall of any class.
  • Of its descendants, K143057 (Philips Medical Systems, 2014) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K081983.

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. 2010, this device’s year, is highlighted.

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 central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Indications for use as stated in the FDA summary.

Also cleared against K081983

1 other device cites the same predicate.

  • K131032Philips Suresigns CentralPhilips Medical Systems · 2013

More from Philips Medical Systems

127 FDA decisions under this applicant name. See the company

  • P180028/S019HeartStart FRx Defibrillator (861304)Philips Medical Systems · 2026
  • P180028/S018HeartStart FRx DefibrillatorPhilips Medical Systems · 2026
  • P180028/S017HeartStart FRx Defibrillator and HeartStart SMART Pads IIPhilips Medical Systems · 2025
  • P180028/S016HeartStart FRx Defibrillator (861304)Philips Medical Systems · 2025
  • P180028/S015HeartStart FRx DefibrillatorPhilips Medical Systems · 2025

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K102495 · printed Nov 3, 2026

Cite this page

510(k) Report. “K102495: M3290B Intellivue Information Center Software, Release a.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102495

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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