Cleared Traditional

F&P myAirvo 3 (K222292) - FDA 510(k) Clearance

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

K222292 · Fisher & Paykel Healthcare · Anesthesiology device
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May 2024
Decision
649d
Days
Class 2
Risk

K222292 is an FDA 510(k) clearance for the F&P myAirvo 3. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Healthcare (Manukau, NZ). The FDA issued a Cleared decision on May 8, 2024 after a review of 649 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Fisher & Paykel Healthcare devices

Submission Details

510(k) Number K222292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2022
Decision Date May 08, 2024
Days to Decision 649 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
509d slower than avg
Panel avg: 140d · This submission: 649d
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 54
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K222292.
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
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F&P Optiflow Oxygen Kit (AA451J)
K233821 · Fisher &Paykel Healthcare , Ltd. · Jun 2024
F&P Optiflow+ Duet Nasal Cannula
K231956 · Fisher &Paykel Healthcare , Ltd. · Feb 2024
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
K230559 · Medline Industries, Inc. · Oct 2023
BONHAWA Respiratory Humidifier
K223863 · Telesair, Inc. · Oct 2023