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The Tracker / August 2026 / K262268

510(k) cleared

Optiflow Oxygen Kit (AA484J)

Fisher and Paykel Healthcare Limited · Aug 27, 2026 · K262268

FDA cleared the Optiflow Oxygen Kit (AA484J) from Fisher and Paykel Healthcare Limited on Aug 27, 2026 under K262268, a special 510(k). The device falls under product code BTT, Humidifier, Respiratory Gas, (Direct Patient Interface), regulated at 21 CFR 868.5450 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jul 6, 2026. The decision came 52 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Fisher and Paykel Healthcare Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262268?

K262268 is the FDA 510(k) for Optiflow Oxygen Kit (AA484J), submitted by Fisher and Paykel Healthcare Limited. FDA's decision date was Aug 27, 2026, under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)).

Who makes the Optiflow Oxygen Kit (AA484J)?

Fisher and Paykel Healthcare Limited, based in Auckland, is the applicant of record for K262268.

How long did the K262268 review take?

FDA received the submission on Jul 6, 2026 and issued its decision on Aug 27, 2026, 52 days later.

← All decisions in August 2026