# K243917: F&P Optiflow Air/Oxygen Flow Source

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jul 14, 2025 after 206 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913368 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161718: MaxBlend 2, MaxBlend Lite, Maxtec, LLC (2016) Summary page 5.
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 5.

## Indications for use
This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals. This product is not intended to be used on patients with bypassed upper airways. This product is not intended to be life-sustaining or life-supporting. This product is not intended for apneic ventilation.

Source page: https://510kreport.com/device/K243917
Methodology: https://510kreport.com/methodology