Cleared Traditional

K221338 - F&P Airvo 3 (FDA 510(k) Clearance)

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

K221338 · Fisher & Paykel Healthcare · Anesthesiology device
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Jan 2023
Decision
263d
Days
Class 2
Risk

K221338 is an FDA 510(k) clearance for the F&P Airvo 3. Classified as High Flow/high Velocity Humidified Oxygen Delivery Device (product code QAV), Class II - Special Controls.

Submitted by Fisher & Paykel Healthcare (Manukau, NZ). The FDA issued a Cleared decision on January 27, 2023 after a review of 263 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5454 - 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.

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Submission Details

510(k) Number K221338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date January 27, 2023
Days to Decision 263 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 139d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAV High Flow/high Velocity Humidified Oxygen Delivery Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5454
Definition Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification.
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 - QAV High Flow/high Velocity Humidified Oxygen Delivery Device

Devices cleared under the same product code (QAV) and FDA review panel - the closest regulatory comparables to K221338.
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