# K253479: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

- Pathway: 510(k) (Special)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Dec 19, 2025 after 66 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234058: F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility  (AA041J), Fisher & Paykel Healthcare, Ltd. (2024) Summary page 5.

## Indications for use
This product is intended for delivery of respiratory gases to adult patients in hospitals. This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals. Qualitative carbon dioxide (CO2) 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, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care or airway management. This product is not intended for apneic ventilation. This product is not indicated for use during CPR.

Source page: https://510kreport.com/device/K253479
Methodology: https://510kreport.com/methodology