FDA Codifies Class II Status for OTC Infant Pulse Rate and Oxygen Saturation Monitors, Opening 510(k) Route

FDA Finalizes Class II Classification for OTC Infant Pulse Rate and Oxygen Saturation Monitors

On October 9, 2026, the U.S. Food and Drug Administration (FDA) published a final order in the Federal Register adding the infant pulse rate and oxygen saturation monitor for over-the-counter (OTC) use to 21 CFR 870.2705, classifying it as Class II with special controls. The order took effect on the same day.

This was not a new device authorization. On December 14, 2022, FDA received a De Novo classification request from Owlet Baby Care for its Dream Sock device. On November 8, 2023, FDA issued an order classifying the device as Class II. The October 2026 action codifies that classification into the federal regulations, giving it a formal place in the regulatory text.

What the device is

Under the regulatory definition, the device uses photoplethysmography (PPG) to measure an infant's pulse rate and oxygen saturation for OTC use. The device may include an alarm function to alert caregivers when vital signs fall outside preset thresholds. The definition refers to infants, not adults, and not to continuous monitoring in hospital settings.

From Class III to Class II: what changes

In the United States, devices marketed after May 28, 1976, that had not previously been classified automatically fall into Class III by statute and require premarket approval. The purpose of the De Novo pathway is to move a device off that default track.

Once classified as Class II, this device can serve as a predicate. Subsequent devices seeking to demonstrate substantial equivalence may use the 510(k) pathway instead of submitting another De Novo request or a premarket approval (PMA) application. According to the Federal Register order, this reduces regulatory burden while allowing patients to access useful new products sooner.

Seven special controls: detailed evidence expectations

Class II does not mean a lighter evidence package. The special controls finalized with the order set out specific evidence requirements. They address, among other things:

• Clinical performance testing to demonstrate that the device works as designed under its intended conditions of use. The order specifically calls for evaluation of confounding factors such as skin tone, demonstration of output consistency, data sources that cover the target population's actual use scenarios, and assessment of all adverse events, including skin irritation.
• Software requirements covering verification, validation, and hazard analysis. Documentation must describe the algorithm and its inputs and outputs, and must establish acceptance controls for sensor data quality.
• Non-clinical testing to demonstrate that the device can identify valid photoplethysmographic signals, and validation of the alarm function.
• Biocompatibility evidence for skin-contact components, and electrical safety and electromagnetic compatibility testing for electrical components.
• Human factors testing to demonstrate that caregivers can correctly use the device based on labeling alone, correctly understand the output, and know what to do next.
• Labeling that states the applicable and non-applicable populations, monitoring conditions, what is measured and how results should be interpreted, circumstances in which performance may fall short of expectations, and cleaning methods and frequency.

Scope: limited to OTC infant PPG monitoring

The order has a narrow scope. It covers OTC infant heart rate and oxygen saturation monitors based on photoplethysmography. Prescription oximeters, adult wearable devices, and hospital monitors are not included in this classification regulation.

Effective date and classification date

The dates should be distinguished. The order took effect on October 9, 2026, but the classification applies from November 8, 2023. The source documents present these two dates separately, and they should not be conflated when cited.

Sources and verification

Sources: Federal Register document 2026-20726, Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use, 91 FR 64615, published October 9, 2026, https://www.federalregister.gov/documents/2026/10/09/2026-20726/medical-devices-cardiovascular-devices-classification-of-the-infant-pulse-rate-and-oxygen-saturation; and the current text of 21 CFR 870.2705 in the Electronic Code of Federal Regulations (eCFR), https://www.ecfr.gov/current/title-21/section-870.2705.

Verification scope and access date: On October 19, 2026, the full Federal Register text was reviewed, including the summary, effective date, De Novo background, and special controls, together with the current eCFR text of the section. The FDA CDRH New update list was also checked to confirm the date on which the order was listed.

Applicability note: This article interprets publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company, or regulatory application. The official source texts remain controlling for the classification, special controls, and dates, and the information may change with subsequent official updates.

AIMEILI Regulatory Interpretation

The significance of this final order lies in regulatory certainty. The De Novo order in 2023 established a marketing authorization for the original device and created a new device type. The 2026 codification places that device type directly into 21 CFR 870.2705, so the classification and its special controls are now part of the regulatory framework rather than being reflected only in the De Novo decision.

For follow-on manufacturers, the key change is predicate availability. A new OTC infant PPG monitor can pursue a 510(k) by demonstrating substantial equivalence to the De Novo-authorized device, provided it meets the applicable special controls. This avoids a new De Novo request and avoids the PMA pathway. However, the special controls indicate that FDA expects robust evidence in areas such as skin-tone confounding, output consistency, software algorithm documentation, sensor data quality controls, alarm validation, biocompatibility, electrical safety and electromagnetic compatibility, human factors, and labeling.

The scope is deliberately limited. The regulation covers OTC infant PPG-based pulse rate and oxygen saturation monitoring. It does not extend to prescription oximetry, adult wearables, or hospital monitoring. Companies should therefore confirm that their intended use, target population, and claims fall squarely within 21 CFR 870.2705 before relying on this classification route.

Another practical point is the distinction between the effective date of the order and the applicability date of the classification. The order took effect on October 9, 2026, while the classification applies from November 8, 2023. Regulatory submissions, regulatory intelligence materials, and internal documentation should reflect both dates accurately and avoid combining them into a single date.

Business Impact

For medical device manufacturers, the codification reduces pathway uncertainty for OTC infant pulse rate and oxygen saturation monitors. New entrants can plan for a 510(k) strategy with a known predicate and a defined special controls framework, rather than budgeting for a De Novo request or a PMA.

At the same time, the evidence burden remains substantial. Clinical performance testing that addresses skin tone and other confounding factors, human factors validation with caregivers, software documentation, alarm validation, and labeling comprehension testing can materially affect development timelines and costs. Companies should incorporate these requirements early into product design, clinical study design, and usability engineering.

For distributors and regulatory affairs teams, the order provides a clearer basis for portfolio assessment and due diligence. Products marketed or proposed for OTC infant monitoring should be reviewed against the device definition and special controls. Labeling claims, intended-use statements, and alarm features should be aligned with the regulation to avoid positioning a product outside the scope of 21 CFR 870.2705.

For CROs and consultancies, the final order creates a defined regulatory pathway for a specialized consumer-oriented device category. Supporting evidence packages will need to integrate clinical performance, software, human factors, biocompatibility, electrical safety, and labeling requirements into a coherent 510(k) submission strategy. The overall effect is a more predictable route to market, but one that still requires disciplined evidence generation and careful regulatory planning.