510(k) Report

510(k) · Cleared

Cleared

Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables

K012992510(k) SpecialCleared Oct 3, 200127-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 Oct 3, 2001 as substantially equivalent to K000126 (Masimo Corp., 2000) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1994. 45 later devices descend from it.

Decided
Oct 3, 2001
Review
27 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944760 (1994). 2 ancestors in all. 45 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2012: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2015: 3 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2016: 2 descendants cleared2018: 4 descendants cleared2017: 3 descendants cleared2019: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2022: 3 descendants cleared2023: 6 descendants cleared2026: 5 descendants cleared2025: 6 descendants cleared2024: 1 descendant clearedK944760 · Dura-Y Oxygen Transducer, Ear Clip · Nellcor, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 13 descendants5 generations forward: 8 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants K944760 · Dura-Y Oxygen Transducer, Ear Clip · Nellcor, Inc. · 19940+5
  1. Root · 1 generation backK944760 Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994
  2. This deviceK012992 Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of…Masimo Corp. · 2001
  3. Descendant · cites it directly · 38 of its ownK111621 Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS…Masimo Corporation · 2011
  4. Descendant · cites it directly · 37 of its ownK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
  5. Descendant · 2 generations on · 34 of its ownK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
  6. Descendant · 3 generations on · 31 of its ownK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
  7. Descendant · 4 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 22013: 12014: 12015: 32016: 22017: 32018: 42019: 42020: 12021: 12022: 32023: 62024: 12025: 62026: 5
2010high 6 (2023) · low 1 (2010)2026

Most influential descendants

Showing 5 of 45 · See all
  • K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation · 2011 · cites it directly38descendants
  • K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012 · cites it directly37descendants
  • K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH · 2015 · 2 generations on34descendants
  • K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH · 2016 · 3 generations on31descendants
  • K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc.1994—
0 (this device)K012992Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors…Masimo Corp.2001—
+1K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry…Masimo Corporation2011—
+1K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation2012—
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH20151
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH20161
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue…Philips Medizin Systeme Boeblingen GmbH20174

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201220
201310
201410
201530
201620
201730
201840
201940
202010
202110
202230
202360
202410
202560
202650
FIG. 1 — Lineage of K012992, 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 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
*K000126Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric…
Summary page 1
…nd Electrode (74DSA) (870.2900) Oximeter, Ear (74DPZ) (870.2710) Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and Cables 510(k) Number - K000126 Nellcor DURA-Y Oxygen Transducer, Ear Clip - 510(k) Number - K944760 The Masimo series of oximetry sensors measure the light abs…
Masimo Corp.2000—
*K944760Dura-Y Oxygen Transducer, Ear Clip
Summary page 1
…imo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and Cables 510(k) Number - K000126 Nellcor DURA-Y Oxygen Transducer, Ear Clip - 510(k) Number - K944760 The Masimo series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED’s). Oxygen satur…
Nellcor, Inc.1994—

Also cleared against K000126: 5 other devices →

What descends from it? (45)

See all 45

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

NumberDeviceApplicantDecidedDescendants
K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138
K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237
K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K111621 (Masimo Corporation, 2011) has gone furthest, with 38 descendants of its own.
  • 5 other devices also cite its predicate K000126.

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 following additional Masimo Sensors are indicated for the continuous noninvasive functional oxygen saturation of arterial hemoglobin (SpO;) and pulse rate:

Single use oximetry sensor intended for adults and pediatrics greater than 10 kg

Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg

Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K000126

5 other devices cite the same predicate.

  • K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp. · 2004
  • K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo Corp. · 2003
  • K022037Xltek Sleep SystemExcel Tech., Ltd. · 2002
  • K013792Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo Corp. · 2001
  • K011851Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo Corp. · 2001

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
  • 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

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/K012992 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012992: Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012992

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026