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

Fisher & Paykel Healthcare, is a global medical device manufacturer driving innovation in healthcare technologies for over 50 years. The company operates with a manufacturing facility in Auckland, New Zealand, and specializes in respiratory care, humidification systems, and therapeutic devices for hospital and home settings.

The company has received 5 FDA 510(k) clearances from 5 total submissions since 2017. Anesthesiology devices represent the dominant category, accounting for approximately 80% of regulatory submissions. The latest clearance was received in 2024, demonstrating continued active development and market engagement.

Fisher & Paykel Healthcare's cleared portfolio includes advanced humidification systems, high-flow respiratory therapy devices, and heated breathing tube technologies. The company also manufactures surgical humidification systems for obstetric and gynecologic applications. These products reflect the company's core expertise in respiratory gas conditioning and non-invasive patient support.

Explore the complete regulatory record, including device names, product codes, and individual clearance dates in the database.