# K233821: F&P Optiflow Oxygen Kit (AA451J)

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jun 13, 2024 after 195 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913368 (1992). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211096: Optiflow Oxygen Kit, Fisher & Paykel Healthcare, Ltd. (2022) Summary page 5.
- K220703: F&P 950 Respiratory Humidifier, Fisher & Paykel Healthcare (2023) Summary page 5.

## Indications for use
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications. It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup. This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.

Source page: https://510kreport.com/device/K233821
Methodology: https://510kreport.com/methodology