Cleared Traditional

K250651 - OptiPAP Junior Flexi Tube US (OPTIPAPFUS) (FDA 510(k) Clearance)

Also includes:
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

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250651 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
260d
Days
Class 2
Risk

K250651 is an FDA 510(k) clearance for the OptiPAP Junior Flexi Tube US (OPTIPAPFUS). Classified as Noninvasive Positive Airway Pressure System, Facility Use (product code SGR), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on November 19, 2025 after a review of 260 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K250651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 139d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SGR Noninvasive Positive Airway Pressure System, Facility Use
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.