510(k) K262268

Optiflow Oxygen Kit (AA484J) by Fisher and Paykel Healthcare Limited — Product Code BTT

K262268 is an FDA 510(k) premarket notification submitted by Fisher and Paykel Healthcare Limited for the device "Optiflow Oxygen Kit (AA484J)". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Fisher and Paykel Healthcare Limited has at least 10 other 510(k) clearances on record.