The FDA has classified the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls), providing a reasonable assurance of safety and effectiveness and reducing regulatory burdens.
Why it matters. This regulatory action affects medical device manufacturers and patients, potentially enhancing access to beneficial innovations.
Upon request, FDA (the Agency or we) has classified the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls), which we have determined will provide a reasonable assurance of the safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the d…
The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hyperoxia monitoring device adjunct to pulse oximetry. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this ac…
The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls).
On December 21, 2020, FDA received Masimo Corporation's request for De Novo classification of the ORi device.
FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act.
PART 870—CARDIOVASCULAR DEVICES 1. The authority citation for part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371. 2. Add § 870.2720 to subpart C to read as follows: § 870.2720 Hyperoxia monitoring device adjunct to pulse oximetry.
Department of Health and Human Services Food and Drug Administration
Annie Abraham, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1264, Silver Spring, MD 20993-0002, 240-402-5219, [email protected].
Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for hyperoxia monitoring devices adjunct to pulse oximetry. This device is therefore subje…
Department of Health and Human Services Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2026-N-10995] AGENCY: Food and Drug Administration, HHS.
