Cleared Special

K262268 - Optiflow Oxygen Kit (AA484J)

K262268 is an FDA 510(k) clearance for Optiflow Oxygen Kit (AA484J), manufactured by Fisher and Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Special 510(k) pathway after a 52-day FDA review.

K262268 · Fisher and Paykel Healthcare Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
52d
Days
Class 2
Risk

K262268 is an FDA 510(k) clearance for the Optiflow Oxygen Kit (AA484J). Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher and Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on August 27, 2026 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fisher and Paykel Healthcare Limited devices

FDA 510(k) Submission Details - K262268

510(k) Number K262268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2026
Decision Date August 27, 2026
Days to Decision 52 days
Submission Type Special
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
88d faster than avg
Panel avg: 140d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

BTT Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K262268.
HVT 2.0
K254078 · Vapotherm, Inc. · Apr 2026
FL-10000U Respiratory Humidifier
K251448 · Flexicare Medical Limited. · Jan 2026
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K251419 · Laboratorios Biogalenic S.A. DE C.V. · Jan 2026
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
K253479 · Fisher &Paykel Healthcare , Ltd. · Dec 2025
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
K250312 · Medline Industries, LP · Jul 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · Fisher &Paykel Healthcare , Ltd. · Jun 2025