# K251611: Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium  (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

- Pathway: 510(k) (Special)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jun 25, 2025 after 29 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 5.

## Indications for use
OPT94X Model: The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals. MYOPT9X Model: The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

Source page: https://510kreport.com/device/K251611
Methodology: https://510kreport.com/methodology