Cleared Traditional

F&P 950 Respiratory Humidifier (K220703) - FDA 510(k) Clearance

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

K220703 · Fisher & Paykel Healthcare · Anesthesiology device
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Jun 2023
Decision
463d
Days
Class 2
Risk

K220703 is an FDA 510(k) clearance for the F&P 950 Respiratory Humidifier. 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 June 16, 2023 after a review of 463 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.

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Submission Details

510(k) Number K220703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2022
Decision Date June 16, 2023
Days to Decision 463 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
323d slower than avg
Panel avg: 140d · This submission: 463d
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 K220703.
F&P 820 Humidification System
K223684 · Fisher &Paykel Healthcare , Ltd. · Sep 2023
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 Optiflow Junior 2/2+ Nasal Cannula Interface Range
K222197 · Fisher &Paykel Healthcare , Ltd. · Apr 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