Cleared Special

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

K253479 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology
Dec 2025
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K253479 is an FDA 510(k) clearance for the Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J), a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on December 19, 2025, 66 days after receiving the submission on October 14, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K253479 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2025
Decision Date December 19, 2025
Days to Decision 66 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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

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