Cleared Traditional

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

K250651 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology

Nov 2025

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K250651 is an FDA 510(k) clearance for 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, a Noninvasive Positive Airway Pressure System, Facility Use (Class II — Special Controls, product code SGR), submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on November 19, 2025, 260 days after receiving the submission on March 4, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K250651 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2025
Decision Date	November 19, 2025
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	SGR — Noninvasive Positive Airway Pressure System, Facility Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5895
Definition	To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure.