510(k) Report

510(k) · Cleared

Cleared

Lnop Blue Oximetry Sensor

K051439510(k) TraditionalCleared Jul 15, 200543-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 Corporation · DQA Oximeter

Cleared on Jul 15, 2005 as substantially equivalent to K042536 (Masimo Corporation, 2005) after a 43-day review. Its family tree reaches back 4 generations to 2000. 39 later devices descend from it.

Decided
Jul 15, 2005
Review
43 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K000126 (2000). 5 ancestors in all, the oldest K853990 (1985). 39 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1985: 1 other ancestor2006: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2013: 2 descendants cleared2023: 4 descendants cleared2020: 3 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2022: 4 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2025: 6 descendants cleared2019: 2 descendants cleared2024: 6 descendants cleared2021: 2 descendants cleared2026: 2 descendants clearedK000126 · Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia · Masimo Corp. · 2000K031330 · Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2003K033296 · Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V · Masimo Corp. · 2004 · recalledK042536 · Masimo Set Rad 57 Pulse CO-Oximeter · Masimo Corporation · 2005 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 5 descendants6 generations forward: 5 descendants7 generations forward: 4 descendants8 generations forward: 4 descendants9 generations forward: 5 descendants10 generations forward: 5 descendants11 generations forward: 6 descendants K042536 · Masimo Set Rad 57 Pulse CO-Oximeter · Masimo Corporation · 2005 · recalledK033296 · Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V · Masimo Corp. · 2004 · recalledK031330 · Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2003K000126 · Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia · Masimo Corp. · 20000+5+10
  1. Root · 4 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
  2. 3 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
  3. 2 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
  4. 1 generation backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
  5. This deviceK051439 Lnop Blue Oximetry SensorMasimo Corporation · 2005
  6. Descendant · cites it directly · 38 of its ownK062268 Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement…Philips Medical Systems North America Co. · 2006
  7. Descendant · 2 generations on · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  8. Descendant · 3 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  9. Descendant · 4 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  10. Descendant · 5 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2006: 12010: 12011: 12013: 22014: 12015: 12017: 12018: 22019: 22020: 32021: 22022: 42023: 42024: 62025: 62026: 2
2006high 6 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 39 · See all
  • K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co. · 2006 · cites it directly38descendants
  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on37descendants
  • K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on36descendants
  • K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 4 generations on35descendants
  • K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 5 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000126Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp.2000—
−3K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…Masimo Corp.2003—
−2K033296Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse…Masimo Corp.20041
−1K042536Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation20051
0 (this device)K051439Lnop Blue Oximetry SensorMasimo Corporation2005—
+1K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option…Philips Medical Systems North America Co.2006—
+2K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201010
201110
201320
201410
201510
201710
201820
201920
202030
202120
202240
202340
202460
202560
202620
FIG. 1 — Lineage of K051439, 2000–2026Source: 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
*K042536Masimo Set Rad 57 Pulse CO-Oximeter
Summary page 1
…2700) Substantially Equivalent Devices: Masirno SET®~Rad 57 Pulse CO-Oximeter 510(k) Number - K042536 Device Description The LNOP Blue Oximetry Sensors are fully compatible disposable sensors for use with Masimo…
Masimo Corporation20051
*—Masimo LNOP Inf-L sensor
Named without a submission number
—

Also cleared against K042536: 1 other device →

What descends from it? (39)

See all 39

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638

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 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K062268 (Philips Medical Systems North America Co., 2006) has gone furthest, with 38 descendants of its own.
  • 1 other device also cites its predicate K042536.

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 LNOP Blue Sensors are indicated for the continuous noninvasive monitoring of fallutional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions in hospitals, hospital-type facilities, mobile, and home environments.

Indications for use as stated in the FDA summary.

Also cleared against K042536

1 other device cites the same predicate.

  • K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006

More from Masimo Corporation

88 FDA decisions under this applicant name. See the company

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K254209Radius VSM and AccessoriesMasimo Corporation · 2026
  • K243324Masimo O3 Regional OximeterMasimo Corporation · 2025

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/K051439 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051439: Lnop Blue Oximetry Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051439

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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