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FDA 510(k)

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

K-Number: K253479 · 2025-12-19

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2025-12-19
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253479. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)?

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K253479.

When was Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) approved by the FDA?

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) received FDA 510(k) clearance on 2025-12-19, under approval number K253479.

What company makes Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)?

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)?

The FDA product code for Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is BTT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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