Cleared Traditional

K222197 - F&P Optiflow Junior 2/2+ Nasal Cannula ...

K222197 is the FDA 510(k) clearance for F&P Optiflow Junior 2/2+ Nasal Cannula ... by Fisher &Paykel Healthcare , Ltd.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K222197 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
258d
Days
Class 2
Risk

K222197 is an FDA 510(k) clearance for the F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on April 6, 2023 after a review of 258 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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 K222197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2022
Decision Date April 06, 2023
Days to Decision 258 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
118d slower than avg
Panel avg: 140d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 81
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K222197.
AirLife DuoTherm™ Humidification System
K231380 · Vyaire Medical, Inc. · Aug 2023
Sterile Water for Inhalation in 1L Flexoval ® bottles.
K223551 · Hometa, Inc. · Aug 2023
F&P 950 Respiratory Humidifier
K220703 · Fisher & Paykel Healthcare · Jun 2023
inspired™ VHB20 Heated Humidifier
K222351 · Vincent Healthcare Products Limited · Dec 2022
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K212031 · Fisher &Paykel Healthcare , Ltd. · Apr 2022
Optiflow Oxygen Kit
K211096 · Fisher &Paykel Healthcare , Ltd. · Jan 2022