Respironics, Inc. - FDA 510(k) Cleared Devices

Respironics, Inc. is an American medical supply company owned by Philips. It specializes in products that improve respiratory functions and is based in Monroeville, Pennsylvania.

The company maintains a strong FDA 510(k) regulatory record spanning from 1977 to 2024. Respironics has received 169 FDA 510(k) clearances from 173 total submissions. The dominant focus is Anesthesiology devices, which represent approximately 90% of all submissions. The latest clearance in 2024 reflects continued regulatory activity.

Recent cleared devices include masks, ventilators, and sleep therapy systems. The company's product portfolio spans respiratory support, anesthesia delivery, and sleep medicine applications. These devices serve critical roles in patient care across multiple clinical settings.

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

Regulatory submissions have been managed by Entela, Inc., Intertek Testing Services and Underwriters Laboratories, Inc.. 1 device has linked clinical trial registered on ClinicalTrials.gov.