Fisher &Paykel Healthcare , Ltd. - FDA 510(k) Cleared Devices

Fisher &Paykel Healthcare, Ltd. is a medical device manufacturer based in Auckland, New Zealand. The company has driven innovation in healthcare technologies for over 50 years.

Fisher &Paykel Healthcare has received 70 FDA 510(k) clearances from 70 total submissions since 1988. The company specializes in Anesthesiology devices, which represent 91% of its regulatory submissions. The latest clearance was granted in 2025, confirming active ongoing development.

Recent cleared devices include high-flow nasal therapy systems, noninvasive ventilation masks, and respiratory support interfaces. The company's product portfolio spans hospital respiratory care, humidification systems, and home-based sleep apnea solutions.

Explore the complete list of device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Fisher & Paykel Healthcare, Ltd. as regulatory consultant.