# K191818: F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 19, 2020 after 258 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: 10 generations back to K913368 (1992). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162553: AirSpiral Heated Breathing Tube, Fisher & Paykel Healthcare (2018) Summary page 4.

## Indications for use
The F&P Optiflow™ 3S nasal cannula is a 14 day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients. This product is designed to be used by appropriately qualified healthcare professionals in a hospital / institutional environment.

Source page: https://510kreport.com/device/K191818
Methodology: https://510kreport.com/methodology