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Pulse Oximetry Accuracy: How Nellcor™ and Masimo SET™ Compare

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Medtronic has been named one of the World's Most Ethical Companies by Ethisphere for the third year in a row!

At Medtronic, we are proud to be recognized as one of the world's most ethical companies, a testament to our unwavering commitment to patient safety. Pulse oximetry technology is crucial in critical care environments, allowing healthcare professionals to accurately monitor patients' oxygen levels and vital signs.1 In this blog, we delve into a detailed comparison of Nellcor™ Pulse Oximetry and Masimo SET™ , focusing on their response times for vital signs and motion detection capabilities. Our goal is to offer healthcare providers essential insights to help them select the most effective pulse oximetry technology for their critical and acute care requirements.

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Nellcor™ pulse oximetry performs better than Masimo™* for patients with dark skin tones†,‡,2,3

23% greater accuracy‡,3

Nellcor™ pulse oximetry demonstrated 23% greater accuracy.

90% fewer dropouts†,2

Nellcor™ pulse oximetry had 90% fewer data dropouts compared to Masimo SETTM, meaning it provided a more reliable and consistent signal during patient monitoring.

31% greater precision†,2

Nellcor™ pulse oximetry had 31% greater precision in all dark skin readings than Masimo SET™* pulse oximetry.

Disclaimer:

Based on recent, independent and prospective studies that assess performance in dark skin pigmentation.

† Accuracy based on study, not funded by Medtronic, that enrolled 146 healthy subjects in the 92-96% saturation range and examined paired readings from Nellcor™ N-595 and Masimo Radical 7™* pulse oximeters generated simultaneously. This study was not designed for head-to-head comparison of the respective devices.

‡ The observational study (not funded by Medtronic) enrolled 319 children with different skin tones undergoing cardiac catheterization and examined paired readings from Nellcor disposable SpO2 adhesive sensors and Masimo reusable child/adult clip sensors generated simultaneously. This study was not designed for head-to-head comparison of the respective devices. All values were calculated by Medtronic as percent difference and should be interpreted as hypothesis generating only.

™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company

Clinical Evidence Comparison: Nellcor™ Oximax Bedside vs. Masimo Radical-7™*

12s

Speed to post§,◊,4

Nellcor™ pulse oximetry has been shown to post on average 12 seconds faster than Masimo SET™* technology.

60%

Motion◊,¶,5

Nellcor™ pulse oximetry sensors demonstrated 60% greater accuracy than Masimo SET® sensors in detecting pulse rate in neonates in the NICU—during both sleep and wakefulness.

74%

Low Perfusion†,◊,2

Nellcor™ pulse oximetry results in 74% less hypoxemic episodes than Masimo technology.

Disclaimer:

™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

† Accuracy based on study, not funded by Medtronic, that enrolled 146 healthy subjects in the 92-96% saturation range and examined paired readings from Nellcor™ N-595 and Masimo Radical 7™* pulse oximeters generated simultaneously. This study was not designed for head-to-head comparison of the respective devices.

§ The study enrolled 55 mostly healthy, full-term newborn subjects and examined the Nellcor™ pulse oximetry™ OxiMax™ and the Masimo™* Radical 7™* pulse oximeters in a prospective observational monocentric comparative clinical study.

◊ Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2. Please consult the instructions for use and manual for full safety information.

¶ Based on a Medtronic-sponsored single-center study evaluating pulse rate accuracy and oximeter performance in a neonatal intensive care unit (n=29).

Our Nellcor™ pulse oximeters lead the way in equitable patient monitoring.†,‡,2,3

Medtronic: the only FDA-approved pulse oximeter manufacturer dismissed from skin tone accuracy lawsuit

Nellcor™ OxySoft™ sensors maintain accuracy for all skin types.◊,7

Nellcor™ pulse oximetry helps ensure that readings are sensitive and timely, even in the most challenging monitoring conditions.◊,8

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Disclaimer:

™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

† Accuracy based on study, not funded by Medtronic, that enrolled 146 healthy subjects in the 92-96% saturation range and examined paired readings from Nellcor™ N-595 and Masimo Radical 7™* pulse oximeters generated simultaneously. This study was not designed for head-to-head comparison of the respective devices.

◊ Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2. Please consult the instructions for use and manual for full safety information.

Accuracy comparison◊

Inaccurate pulse rate readings may guide clinicians to inappropriate or unnecessary interventions.9,10

Nellcor™ pulse oximetry showed no clinically significant difference from ECG reference.§,4

Nellcor™ OxiMax™ pulse oximetry
Heart rate
compared to ECG4
(correlation coefficient)
r = 0 .894
STRONGLY correlated
Mismatch ≥ 40 bpm
compared to ECG4
(% of patients)		 0%
False bradycardia4
(% of patients)		 0%
Masimo Radical-7™* pulse oximetry
Heart rate
compared to ECG4
(correlation coefficient)		 r = 0.235
WEAKLY correlated
Mismatch ≥ 40 bpm
compared to ECG4
(% of patients)		 31%
False bradycardia4
(% of patients)		 35%

Range Applicability: Ranges apply to Nellcor™ pulse oximetry OXIMAX, MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P sensors; see sensor IFUs for complete information

§ The study enrolled 55 mostly healthy, full-term newborn subjects and examined the Nellcor™ pulse oximetry™ OxiMax™ and the Masimo™* Radical 7™* pulse oximeters in a prospective observational monocentric comparative clinical study

◊ Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2. Please consult the instructions for use and manual for full safety information.

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Nellcor™ Sensor Performance

Based on a blinded low-perfusion evaluation, 

10 out of 10

clinicians recommend using Nellcor™ OxySoft™ during challenging conditions.11,12

Skin protection

Attaching a sensor may pose a risk to the fragile skin of neonates and the elderly

Nellcor™ OxySoft™ sensors are the first
with a gentle, silicone adhesive that 
removes

75%

less skin cells than Masimo LNCS
Neo™* sensors — so you can remove
without pulling fragile skin.#,12,13

# Based on post-market surveillance which may not be indicative of clinical performance.

Workflow

Nellcor™ OxySoft™ sensors 
maintain

85%

adhesiveness after 18 repositions 
compared to Masimo LNCS Neo™*
sensors which lose 50% of
adhesiveness after only two repositions.#,14

Nellcor™ OxySoft™ sensors don’t stick
to themselves and stay adhered

2x

better than Masimo LNCS Neo™* sensors.#,14

Alarm Management

80–99%

of alarms don’t require clinical
intervention.15

Nellcor™ SatSeconds alarm
management may
reduce nuisance alarms 
in the neonate population
by up to

40%.∆ 16,17

# Based on post-market surveillance which may not be indicative of clinical performance.

∆ A third party study showed that at a setting of 50, nuisance alarms were reduced in the neonate population by 40%. Clinical judgment should be used to determine appropriate SatSeconds setting.

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The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.

™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

†Accuracy based on study, not funded by Medtronic, that enrolled 146 healthy subjects in the 92-96% saturation range and examined paired readings from Nellcor™ N-595 and Masimo Radical 7™* pulse oximeters generated simultaneously. This study was not designed for head-to-head comparison of the respective devices.

‡The observational study (not funded by Medtronic) enrolled 319 children with different skin tones undergoing cardiac catheterization and examined paired readings from Nellcor disposable SpO2 adhesive sensors and Masimo reusable child/adult clip sensors generated simultaneously. This study was not designed for head-to-head comparison of the respective devices. All values were calculated by Medtronic as percent difference and should be interpreted as hypothesis generating only.

§ The study enrolled 55 mostly healthy, full-term newborn subjects and examined the Nellcor™ pulse oximetry™ OxiMax™ and the Masimo™* Radical 7™* pulse oximeters in a prospective observational monocentric comparative clinical study.

◊ Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2. Please consult the instructions for use and manual for full safety information.

¶Calculations based on a Medtronic analysis of the data in the referenced studies.

# Based on post-market surveillance which may not be indicative of clinical performance.

∆ A third party study showed that at a setting of 50, nuisance alarms were reduced in the neonate population by 40%. Clinical judgment should be used to determine appropriate SatSeconds setting

  1. Jubran A. Pulse oximetry. Crit Care. 2015 Jul 16;19(1):272. doi: 10.1186/s13054-015-0984-8. PMID: 26179876; PMCID: PMC4504215.
  2. Gudelunas MK, Lipnick M, Hendrickson C, et al. Low perfusion and missed diagnosis of hypoxemia by pulse oximetry in darkly pigmented skin: a prospective study. Anesth Analg. 2024;138(3):552–561. doi:10.1213/ANE.0000000000006755.
  3. Starnes JR, Welch W, Henderson CC, Hudson S, Risney S, Nicholson GT, Doyle TP, Janssen DR, Londergan BP, Parra DA, Slaughter JC, Aliyu MH, Graves JA, Soslow JH. Pulse Oximetry and Skin Tone in Children. N Engl J Med. 2025 Mar 6;392(10):1033-1034. doi: 10.1056/NEJMc2414937. Epub 2025 Feb 12. PMID: 39938116.
  4. Khoury R, Klinger G, Shir Y, Osovsky M, Bromiker R. Monitoring oxygen saturation and heart rate during neonatal transition. comparison between two different pulse oximeters and electrocardiography. J Perinatol. 2021 Apr;41(4):885-890. doi: 10.1038/s41372-020-00881-y. Epub 2020 Nov 30. PMID: 33250516.
  5. Based on internal study: Addison PS, Mannheimer PD, Ochs J. Pulse rate performance of two pulse oximeters during challenging monitoring conditions. 2013.
  6. Based on internal study:  Batchelder K, Sethi R, Eng B, Pinto YJ. Pulse rate performance of two pulse oximeters in the NICU. 2015.
  7. McGonigle S, Dove J, Ting Y-J, Sethi R, Milkes D, Ajizian S. Performance of Nellcor™ pulse oximetry     across varying skin pigmentations: a retrospective analysis. Poster presented at: EBPOM World Congress; 2022; London, UK.
  8. Based on internal technical data: PMB05N (MFR ): RE10096395-Report, Clinical, Motion, Connery OEM Module including the clinical evaluations of Connery 3 .1 board with N-600x and MaxA and MaxFast sensors. PMB10N (LP100 ): RE10143241 - Clinical Report, Springboard OxiCable Motion Study including validation of motion performance during controlled hypoxia with MaxA and Max N over 70-100 % saturation; RE00083396 - VERIFICATION REPORT, MOTION PULSE RATE ACCURACY, OXICABLE; 10143241, CLINICAL REPORT, SPRINGBOARD OXICABLE MOTION STUDY NELL1: RE10011350- Clinical Summary Report, Jupiter, N600x including reference to clinical testing report "Non Invasive Controlled Acute Hypoxia Study – Jupiter: Validate P3 .2 w / MAX-A Gold Sensors during Standard Motion vs. Gold MAX-A w / N-595 (09-20-05 ) " where P3 .2 refers to the prototype N600x with the Nell 1 board. NELL2: EOL NELL3: EOL N595: 10047614 - Saturation and Pulse Rate Comparative performance of the N-595 During Combined Motion and Low Perfusion (Clinical report including the validation of motion and low perfusion conditions combined with N-595 /Max A ); 10035078 - N595 Standard Motion Study Summary Report Saturation and Pulse Rate Accuracy of the N595 During Standard Motions with N595 /Max A and N395 /D25.
  9. Rabi Y, Dawson JA. Oxygen therapy and oximetry in the delivery room. Semin Fetal Neonatal Med. 2013 Dec;18(6):330-5. doi: 10.1016/j.siny.2013.08.007. Epub 2013 Sep 10. PMID: 24035476.
  10. Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Reprint). Pediatrics. 2015 Nov;136 Suppl 2:S196-218. doi: 10.1542/peds.2015-3373G. Epub 2015 Oct 14. PMID: 26471383.
  11. Based on internal report: RE00368468 RevA - Expanded Claims Bench Test Report.
  12. Based on internal report RE00357465 Rev A Marketing validation report from a blinded hands-on evaluation conducted with 12 clinicians ( RNs, RTs), April 2021.
  13. Based on internal test-report CSR 2022 03 15 v.1.0 - cyberDERM S21-15 cyberDERM post-market gentleness comparison of pulse oximeter sensors on adults with fragile skin.
  14. Based on internal test-report CSR 2022 04 18 v.1.0 - cyberDERM S21-16 cyberDERM post-market adhesive comparison reapplication test.
  15. Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268. PMID: 22839984.
  16. Brostowicz HM. Oxygen Saturation in the Neonatal Intensive Care Unit: Evaluation of a New Alarm Management. American Academy of Pediatrics National Conference and Exhibition. October 2009.
  17. Stefanescu BM, O’Shea TM, Haury F, Carlo WA, Slaughter JC. Improved Filtering of Pulse Oximeter Monitoring Alarms in the Neonatal ICU: Bedside Significance. Respir Care. 2016 Jan;61(1):85-9. doi: 10.4187/ respcare.04177. Epub 2015 Oct 27. PMID: 26508772.

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