510(k) Report

510(k) · Cleared

Cleared

LNCS Oximetry Sensors

K041815510(k) SpecialCleared Jul 29, 200423-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 Jul 29, 2004 as substantially equivalent to K031330 (Masimo Corp., 2003) and 2 other predicates after a 23-day review. Its family tree reaches back 13 generations to 1994. 86 later devices descend from it.

Decided
Jul 29, 2004
Review
23 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
3

Its longest line of descent runs back 13 generations to K941811 (1994). 64 ancestors in all, the oldest K863784 (1986). 86 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2000: 11 other ancestors1999: 7 other ancestors1986: 1 other ancestor1998: 5 other ancestors1996: 2 other ancestors2002: 2 other ancestors2001: 2 other ancestors1997: 4 other ancestors1995: 3 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 4 other ancestors1990: 2 other ancestors1989: 1 other ancestor1987: 1 other ancestor2008: 2 descendants cleared2006: 1 descendant cleared2009: 4 descendants cleared2011: 4 descendants cleared2005: 1 descendant cleared2010: 5 descendants cleared2012: 3 descendants cleared2022: 5 descendants cleared2019: 7 descendants cleared2015: 4 descendants cleared2014: 1 descendant cleared2017: 4 descendants cleared2013: 1 descendant cleared2016: 2 descendants cleared2024: 3 descendants cleared2025: 12 descendants cleared2020: 5 descendants cleared2018: 8 descendants cleared2026: 7 descendants cleared2021: 1 descendant cleared2023: 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) ×7: 7 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003) K040259 · Masimo Set Intellivue Pulse Oximeter Module · Masimo Corp. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 5 other ancestors5 generations back: 30 other ancestors6 generations back: 8 other ancestors 1 generation forward: 9 descendants2 generations forward: 8 descendants3 generations forward: 8 descendants4 generations forward: 7 descendants5 generations forward: 27 descendants6 generations forward: 13 descendants7 generations forward: 8 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants K040259 · Masimo Set Intellivue Pulse Oximeter Module · Masimo Corp. · 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. · 1994−10−50+5
  1. Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 9 generations between
  3. 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  4. 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  5. 1 generation backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
  6. This deviceK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
  7. Descendant · cites it directly · 85 of its ownK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
  8. Descendant · 2 generations on · 62 of its ownK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
  9. Descendant · 3 generations on · 59 of its ownK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
  10. Descendant · 2 generations on · 39 of its ownK100617 Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010
  11. Descendant · 3 generations on · 38 of its ownK111621 Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS…Masimo Corporation · 2011
Show all 13 generations
  1. Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 12 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 11 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 10 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 9 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 8 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 7 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 6 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 5 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 4 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 1 generation backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
  14. This deviceK041815 LNCS Oximetry SensorsMasimo Corp. · 2004

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22009: 42010: 52011: 42012: 32013: 12014: 12015: 42016: 22017: 42018: 82019: 72020: 52021: 12022: 52023: 62024: 32025: 122026: 7
2005high 12 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 86 · See all
  • K051212Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · cites it directly85descendants
  • K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010 · 2 generations on62descendants
  • K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011 · 3 generations on59descendants
  • K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010 · 2 generations on39descendants
  • K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation · 2011 · 3 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−12K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−11K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−10K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−9K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−8K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−7K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−6K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−5K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−4K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−3K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−2K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−1K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004—
0 (this device)K041815LNCS Oximetry SensorsMasimo Corp.2004—
+1K051212Modification to LNCS Oximetry SensorsMasimo Corporation20055
+2K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation2010—
+3K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation2011—
+2K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation2010—
+3K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry…Masimo Corporation2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198910
199020
199240
199320
199420
199530
199620
199740
199850
199970
2000110
200120
200220
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
200940
201050
201140
201230
201310
201410
201540
201620
201740
201880
201970
202050
202110
202250
202360
202430
2025120
202670
FIG. 1 — Lineage of K041815, 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? (3)

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
…Oximeter with SatShareTM and LNOP scries of Sensors and Cables 510(k) Number - K031330 Masimo SET Intellivue Pulse Oximeter Module…
Masimo Corp.2003—
*K040259Masimo Set Intellivue Pulse Oximeter Module
Summary page 1
…) Number - K031330 Masimo SET Intellivue Pulse Oximeter Module 5 10(k) Number - K040259 SP02.COM A, P, I, N, RS-I Pulse Oximeter Sensors…
Masimo Corp.2004—
*K033298SPO2.Com Oximetry Sensors, Multiple Models
Summary page 1
…mber - K040259 SP02.COM A, P, I, N, RS-I Pulse Oximeter Sensors 510(k) Number - K033298 Device Description The LNCS Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo…
Masimo Corp.2003—

Also cleared against K031330: 13 other devices →

What descends from it? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K051212Modification to LNCS Oximetry SensorsMasimo Corporation200585
K060143LNCS and SPO2.Com SensorsMasimo Corporation200610
K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083
K083719LNCS Oximetry SensorsMasimo Corporation20092
K083622LNCS Oximetry SensorsMasimo Corporation20091
K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081
K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110
K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100
K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090

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 64 ancestors have a recall of any class.
  • Of its descendants, K051212 (Masimo Corporation, 2005) has gone furthest, with 85 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 LNCS Sensors and Cables are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an SP 2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

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
  • K041204NC SP02 Adapter CableMasimo Corp. · 2004

More from Masimo Corp.

28 FDA decisions under this applicant name. See the company

  • K041204NC SP02 Adapter CableMasimo Corp. · 2004
  • K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo 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/K041815 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041815: LNCS Oximetry Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041815

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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