# K201723: F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 16, 2021 after 266 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.
2 later devices descend from it; 1 cites it directly.
0 of 25 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.

## Most influential descendants
- K234058: F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility  (AA041J) (2024), 1 descendant of its own
- K253479: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (2025), 0 descendants of its own

## Indications for use
This product is a single-patient-use device that delivers respiratory gases to adult patients in hospitals and long-term care facilities. This product is indicated for the delivery of Nasal High Flow (NHF) and Low Flow Oxygen to spontaneously breathing patients by appropriately qualified healthcare professionals. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms. This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation.

Source page: https://510kreport.com/device/K201723
Methodology: https://510kreport.com/methodology