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.
Clearance details
- Applicant
- Fisher and Paykel Healthcare Limited
- Product code
- 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
Recent devices under product code BTT
view all- K254078 — HVT 2.0
- K251448 — FL-10000U Respiratory Humidifier
- K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
More clearances from Fisher and Paykel Healthcare Limited
view all- K233829 — Nova Micro Pillows Mask Small A Model (NVP1SA) +7 more
- K173060 — F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
- K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
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.