Optiflow Oxygen Kit (AA484J)— 510(k) K262268
Substantially EquivalentFisher and Paykel Healthcare Limited
FDA 510(k) clearance K262268 for Optiflow Oxygen Kit (AA484J), Substantially Equivalent on 2026-08-27. Applicant: Fisher and Paykel Healthcare Limited. Device class: 2.
Summary
Fisher and Paykel Healthcare's Optiflow Oxygen Kit, model AA484J, is filed under product code BTT, respiratory gas humidifiers with a direct patient interface.
Class II, 21 CFR 868.5450. Anesthesiology is both the classification panel and the review panel, and the submission type is Special.
Fisher and Paykel filed from Auckland, New Zealand. FDA found it substantially equivalent 52 calendar days after receipt (July 6 to August 27, 2026).
Clearance details
- Applicant
- Fisher and Paykel Healthcare Limited
- Product code
- Product code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Auckland, NZ
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Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.