Introduction
On January 7, 2025, the Food and Drug Administration (FDA) introduced a transformative draft GUIDANCE DOCUMENT for Pulse Oximeters for Medical Purposes, hereafter called “draft guidance”. In this draft guidance, what exactly has changed for FDA-approved pulse oximeters? How do these updates aim to address long-standing healthcare disparities? And what does it mean for the future of medical device standards and patient care? Delve into this blog and gain valuable insights with us.
Why did FDA update the premarket permission 510(k) for pulse oximeters?
The draft guidance aims to address pulse oximeters significance on monitoring blood oxygen levels in various health conditions. During the COVID-19 pandemic from 2020, pulse oximeter readings could determine hospital admissions or access to lifesaving medications, which heightened awareness of how darker skin tones affect accuracy, and further exposed significant racial disparities in healthcare.
In 2023, California Attorney General Rob Bonta, leading a coalition of 25 attorneys general, urged the FDA to strengthen pulse oximeter guidance and issue clear warning labels about inaccurate pulse oximeter readings for patients of darker skin tones[1].
The FDA has worked to improve pulse oximeter accuracy for individuals with darker skin tones. A safety communication in February 2021 highlighted accuracy concerns, followed by proposed evaluation strategies in November 2023 and discussions on premarket study improvements in February 2024[2]. Finally, in January 2025, the FDA published draft guidance on pulse oximeter devices used in healthcare, inviting public comments. Once finalized, this guidance will supersede the former Pulse Oximeters – Premarket Notification Submissions [510(k)s] Guidance published early in 2013, hereafter called “2013 guidance”, reflecting the agency’s commitment to addressing these critical disparities.
What has changed in the 2025 FDA draft guidance for pulse oximeters?
Increased attention to pulse oximeter accuracy in dark skin
1. Increased amount of dark skin tone lab data
Before the draft guidance, when seeking a 510(k) submission, manufacturers used to submit minimal data, with only 4.1% of FDA clearance summaries referencing diverse skin tones. Therefore, the draft guidance now requires manufacturers to include increased representation of dark-skinned individuals in clinical data for pulse oximeters.
Understanding the working mechanism of pulse oximeter devices helps understand why the upgradation of this regulation matters. A pulse oximeter measures blood oxygen saturation using red and near-infrared light. The deoxyhemoglobin mainly absorbs red light, and the oxyhemoglobin absorbs more infrared light. But when it comes to darker skin, the melanin, a pigment in the skin, also absorbs these wavelengths, resulting in inaccurate SpO2 readings. It increases the risk of undetected hypoxemia[3].
To address these limitations, the FDA has strengthened testing requirements in the draft guidance. The previous FDA guideline required 200 data points from 10 subjects. The updated draft guideline recommends 3,000 data points and a larger sample size of 150 or more participants to ensure accuracy across diverse skin tones.
2. Standardized skin tone assessment
Before the draft guidance, manufacturers used simplistic terms like “dark” or “light” or relied on ethnic labels, often misclassifying skin tones. Outdated scales, like the Fitzpatrick Scale[4], with only six shades, failed to represent real-world diversity, leading to unsatisfying device performance for darker-skinned individuals.
In the draft guidance, the FDA recommends that manufacturers should evaluate the forehead pigmentation of study participants through visual assessment using the Monk Skin Tone (MST) Scale[5] which includes a fuller range of darker tones, and by calculating the Individual Typology Angle (ITA)[6], an objective measurement based on spectrophotometric data.
To be more specific, the draft guidance requires studies to include 150+ healthy participants and ensure ≥30% data pairs per MST group (MST 1-4, 5-7, 8-10). It also introduces stricter success criteria, such as Arms < 3% and SpO₂ bias limits (<3.5% for 70% ≤ SaO₂ ≤ 85% and <1.5% for 85% < SaO₂ ≤ 100%), to address known disparities.
The Individual Typology Angle (ITA) Measurement (at right)
What other factors have been stressed for FDA-approved pulse oximeters?
1. Expanded scope of the guideline to cover OLK&QYU pulse oximeters
This draft guidance has expanded its scope of application to include product codes OLK and QYU as FDA approved pulse oximeters, where OLK refers to pulse oximeters for over-the-counter use and QYU refers to infant pulse rate and oxygen saturation monitors for over-the-counter use.
2. Additional considerations for pulse oximeters intended under 12
Previously, the guidelines for pediatric FDA-approved pulse oximeters relied heavily on adult performance data, with limited pediatric-specific requirements, potentially leading to accuracy gaps in vulnerable populations. The American Academy of Pediatrics (AAP) has also emphasized the need for reliable pulse oximetry in newborn screenings for critical congenital heart disease (CCHD)[7].
The draft guidance now requires pediatric-specific testing, including validation across diverse skin tones using tools like the MST Scale and ITA. For neonates and other pediatric subgroups, additional arterial samples are recommended to verify sensor fit and performance. Manufacturers are required to report detailed demographics, percent modulation ranges, and justify sample size and SaO2 ranges, ensuring accuracy and reliability for pediatric use.
3. Additional usability testing for non-traditional pulse oximeters: Wristbands, rings, …
Pulse oximeters are transitioning from supplementary clinical tools to primary healthcare monitoring devices. Traditional pulse oximeters are fingertip-based devices primarily used in hospitals and clinics, combined with a large patient monitoring machine. However, the increasing demand for health monitoring outside the clinic environment is leading to the development of flexible, wearable pulse oximeters for continuous, real-time monitoring[8]. In recent years, non-traditional pulse oximeter designs have enabled health tracking on alternative body sites like the earlobe, forehead, and even tooth pulp. These advancements are expanding oximeters’ applications into personal care, chronic disease management, and home sleep testing.
Previously, when seeking FDA certification, these devices were primarily proven validated for standard fingertip placement. However, with the diversification of pulse oximeter wearing locations, the FDA recognized the need to revise guidelines to ensure proper oversight of the growing pulse oximetry market.
The draft guidance requires early and ongoing evaluations for innovative pulse oximeters used in non-standard locations, such as the forehead and earlobe, to guarantee their accuracy and usability. It mentions rigorous testing to minimize errors, such as motion artifacts or improper placement, improving reliability for diverse clinical scenarios and vulnerable populations, including neonates or patients with poor circulation.
How does the market react to the FDA’s draft guideline for pulse oximeters?
Will 510(k) approval get tougher for pulse oximeter manufacturers?
For pulse oximeters already received FDA clearance, the FDA pointed out that pulse oximeters with the following significant modifications should require a new 510(k) submission and update labeling accordingly.
- Electro-optical sensor
- SpO2 algorithms
- Intended patient populations
- Input parameters of a SpO2 software function
- …
The news has sent ripples through the healthcare and medical device sectors. To date, the FDA has cleared over 500 pulse oximeters, including popular models like Viatom Oxyfit, Viatom O2Ring, Viatom Checkme O2 Series, Masimo Rad-57, Nonin Onyx Vantage 9590, Zacurate Pro Series 500DL, Contec CMS50D. But do these products meet the new standards? If not, will manufacturers scramble to comply with stricter testing and labeling requirements? Furthermore, how much will additional testing and research cost? And will this eventually lead to higher prices for future pulse oximeters?
For healthcare providers and consumers, does this guidance affect their buying options? Are clinics and patients growing more cautious, leaning toward pulse oximeters that meet the updated FDA guidelines, while normal users keep buying general wellness trackers? And could this divide redefine a two-tiered market in the pulse oximeter industry: FDA-approved pulse oximeters for clinical use, and unregulated pulse oximeters for general health monitoring?
Public questioning guidance’s impact on pulse oximeter affordability and equity
Since its release on January 7, the draft guidance has been open for public comment until March 10. So far, the public debate mainly focuses on the challenge of balancing improved device reliability with equitable access. Some researchers advocate for enhanced transparency measures, such as standardized on-device labeling with FDA clearance designations and QR codes carrying performance data. Other experts have highlighted potential drawbacks, including rising costs and shrinking accessibility due to more extensive study requirements. Additionally, some point out that the guidance applies solely to medical pulse oximeters, leaving users of non-FDA-cleared devices in-home care and resource-limited communities facing ongoing challenges[9].
As this marks the first major update in over a decade since the 2013 guidance, the public holds that regulators must carefully balance accuracy, affordability, and accessibility before finalizing the new guidelines.
What are Viatom’s next steps as a leading pulse oximeter player?
- Viatom Winning Place as Preferred Choice in Oximeter Application Market
The shift has created a mixed bag of challenges and opportunities, and Viatom has simultaneously championed policies that ensure a balance between innovation and equitable access. With an impressive sampling rate, ample storage capacity, and seamless data transmission, Viatom’s Checkme O2 Series precisely analyzes sleep patterns and simplifies home sleep test (HST) and sleep apnea diagnosis for thousands of people.
Recently, Viatom’s O2Ring pulse oximeter received FDA approval, marking another milestone in its portfolio. So far, Viatom has held different types of FDA-approved wearable pulse oximeters, covering various monitoring scenarios:
- Fingertip pulse oximeter: Viatom Oxyfit
- Ring pulse oximeter: Viatom O2Ring
- Wrist pulse oximeter: Viatom Checkme O2 Series
- Viatom Gains Official Recognition by Authorities
Viatom is consistently delivering medical devices that meet the highest standards of quality. For example, a research team from the University of Oxford monitored hypoxemia and sleep in 50 hospitalized sleep-disordered breathing (SDB) patients over 7 days from November 2022 to January 2023. Their findings indicate that the Viatom Checkme O2 Series pulse oximeter is highly accurate and reliable, effectively capturing hypoxemia events and performing comparably to traditional hospital equipment[10].
As a professional medical devices manufacturer, Viatom is always serious about the critical need for equitable pulse oximetry performance across all skin tones. Viatom has conducted various rigorous studies to validate the performance of pulse oximeters’ accuracy on individuals with varying pigmentation. For example, our 2019 and 2022 studies (see attached reports), conducted with representative sample sizes and rigorous protocols, demonstrated consistent data accuracy for all tested skin pigmentation levels.
Wrapping Up
As a pioneer of innovative wearable pulse oximetry, we are open to evolving guidance. Viatom has continuously striven to advance high-quality medical devices together with equitable patient monitoring and inclusive telehealth homecare technology.
References:
[1]Attorney General Bonta Leads Multistate Letter Urging FDA to Address Concerns about Dangerous Pulse Oximeter Inaccuracies Impacting Communities of Color (2023)
[2] FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones (2025)
https://www.statnews.com/2025/01/06/pulse-oximeter-fda-draft-guidance-released/
[3] The Problem with Pulse Oximeters: A Long History of Racial Bias (2024)
https://publichealth.jhu.edu/2024/pulse-oximeters-racial-bias
[4] Fitzpatrick scale – Wikipedia (2024)
https://en.wikipedia.org/wiki/Fitzpatrick_scale
[5] Monk Skin Tone Scale – Wikipedia (2024)
https://en.wikipedia.org/wiki/Monk_Skin_Tone_Scale
[6] Skin Color Protocols – Open Oximetry (2024)
https://openoximetry.org/skin-color-quantification/
[7] AAP updates recommendations on use of pulse oximetry to screen newborns for critical congenital heart disease (2024)
https://publications.aap.org/aapnews/news/30947/AAP-updates-recommendations-on-use-of-pulse
[8] Fiber-based quantum-dot pulse oximetry for wearable health monitoring with high wavelength selectivity and photoplethysmogram sensitivity (2023)
https://www.nature.com/articles/s41528-023-00248-1
[9] FDA’s New Pulse Oximeter Guidance: Stricter Standards, Ongoing Challenges (2025)
[10] The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study (2022)
