510(k) Report

510(k) · Cleared

Cleared

Masimo Set Intellivue Pulse Oximeter Module

K040259510(k) TraditionalCleared Apr 22, 200478-day reviewClass II21 CFR 870.2700

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

Masimo Corp. · DQA Oximeter

Cleared on Apr 22, 2004 as substantially equivalent to K031330 (Masimo Corp., 2003) and 1 other predicate after a 78-day review. Its family tree reaches back 12 generations to 1994. 312 later devices descend from it.

Decided
Apr 22, 2004
Review
78 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
2

Its longest line of descent runs back 12 generations to K941811 (1994). 56 ancestors in all, the oldest K872781 (1987). 312 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 11 other ancestors2002: 2 other ancestors1999: 6 other ancestors2001: 2 other ancestors1998: 3 other ancestors1997: 3 other ancestors1995: 3 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 4 other ancestors1990: 2 other ancestors1989: 1 other ancestor1996: 1 other ancestor1987: 1 other ancestor2021: 15 descendants cleared2004: 1 descendant cleared2006: 13 descendants cleared2016: 12 descendants cleared2005: 6 descendants cleared2012: 14 descendants cleared2008: 8 descendants cleared2009: 9 descendants cleared2011: 14 descendants cleared2010: 13 descendants cleared2007: 4 descendants cleared2013: 13 descendants cleared2017: 14 descendants cleared2015: 10 descendants cleared2018: 19 descendants cleared2023: 21 descendants cleared2022: 23 descendants cleared2014: 12 descendants cleared2019: 13 descendants cleared2020: 14 descendants cleared2025: 27 descendants cleared2026: 17 descendants cleared2024: 20 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) ×7: 7 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 29 other ancestors5 generations back: 8 other ancestors 1 generation forward: 7 descendants2 generations forward: 45 descendants3 generations forward: 43 descendants4 generations forward: 58 descendants5 generations forward: 50 descendants6 generations forward: 61 descendants7 generations forward: 38 descendants8 generations forward: 10 descendants K032858 · 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. · 1994−10−50+5
  1. Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 8 generations between
  3. 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  4. 2 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  5. 1 generation backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  6. This deviceK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
  7. Descendant · cites it directly · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  8. Descendant · 2 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  9. Descendant · 2 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  10. Descendant · 2 generations on · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  11. Descendant · 2 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
Show all 12 generations
  1. Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 11 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 10 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 9 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 8 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 7 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 6 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 5 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 4 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 2 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 1 generation backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. This deviceK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004

Showing 5 of 312 descendants. See all descendants

Descendants cleared per year

2004: 12005: 62006: 132007: 42008: 82009: 92010: 132011: 142012: 142013: 132014: 122015: 102016: 122017: 142018: 192019: 132020: 142021: 152022: 232023: 212024: 202025: 272026: 17
2004high 27 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 312 · See all
  • K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly249descendants
  • K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on247descendants
  • K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on234descendants
  • K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on233descendants
  • K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on222descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−11K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−10K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−9K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−8K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−7K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−6K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−5K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−4K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−2K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−1K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
0 (this device)K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004—
+1K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
+2K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
+2K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
+2K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
+2K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199020
199240
199320
199420
199530
199610
199730
199830
199960
2000110
200120
200220
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200560
2006130
200740
200880
200990
2010130
2011140
2012140
2013130
2014120
2015100
2016120
2017140
2018190
2019130
2020140
2021150
2022230
2023210
2024200
2025270
2026170
FIG. 1 — Lineage of K040259, 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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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? (2)

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
*K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…
Summary page 1
…t Devices Masimo SET Radical Pulse Oximeter with SatShareTM and LNOP series of Sensors and Cables 510(k) Number- K031330 Philips Medizin Systeme MP40, MP50, MP60, MP70 and MP90 Intellivue Patie…
Masimo Corp.2003—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 1
…Philips Medizin Systeme MP40, MP50, MP60, MP70 and MP90 Intellivue Patie Monitor - K032858 The Masimo SET® IntelliVue Pulse Oximeter Module is a continuous noninvasive, arterial oxygen saturation and pulse rate monitor.…
Philips Medizin Systeme Boblingen GmbH2003—

Also cleared against K031330: 13 other devices →

What descends from it? (312)

See all 312

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

NumberDeviceApplicantDecidedDescendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249
K041815LNCS Oximetry SensorsMasimo Corp.200486
K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638
K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625
K212876Carescape SpO2 - MasimoMasimo Corporation20212
K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161
K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation20120

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 10 years and passes through 6 companies; a new generation was cleared every 4 months on median.
  • 2 of the 56 ancestors have a recall of any class.
  • Of its descendants, K050762 (Philips Medizin Systeme Boeblingen GmbH, 2005) has gone furthest, with 249 descendants of its own.
  • 13 other devices also cite its predicate K031330.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The Masimo SET® Intellivue Pulse Oximeter Module is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate (measured by an SP 0 2 sensor). The Masimo SET® Intellivue Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Indications for use as stated in the FDA summary.

Also cleared against K031330

13 other devices cite the same predicate.

  • K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc. · 2009
  • K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
  • K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
  • K053269Masimo Set Rad-8 Pulse OximeterMasimo Corporation · 2005
  • K042346LNCS Oximetry SensorsMasimo Corporation · 2004
  • K041815LNCS Oximetry SensorsMasimo Corp. · 2004

More from Masimo Corp.

28 FDA decisions under this applicant name. See the company

  • K041815LNCS Oximetry SensorsMasimo Corp. · 2004
  • K041204NC SP02 Adapter CableMasimo Corp. · 2004
  • K033998Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp. · 2004
  • K040214Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo Corp. · 2004
  • K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp. · 2004

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K040259 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040259: Masimo Set Intellivue Pulse Oximeter Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040259

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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