FDA cleared the OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun from Fisher & Paykel Healthcare, Ltd. on Nov 19, 2025 under K250651, a traditional 510(k). The device falls under product code SGR, Noninvasive Positive Airway Pressure System, Facility Use, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.
FDA logged the submission as received on Mar 4, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Fisher & Paykel Healthcare, Ltd. has one other decision in the tracker over the last 12 months: K253479 (Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)).
Questions & Answers
What did FDA clear under K250651?
K250651 is the FDA 510(k) for OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun, submitted by Fisher & Paykel Healthcare, Ltd.. FDA's decision date was Nov 19, 2025, under product code SGR (Noninvasive Positive Airway Pressure System, Facility Use).
Who makes the OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun?
Fisher & Paykel Healthcare, Ltd., based in Auckland, is the applicant of record for K250651.
How long did the K250651 review take?
FDA received the submission on Mar 4, 2025 and issued its decision on Nov 19, 2025, 260 days later.