Respironics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Altis Full Face Mask, AF531 Oro-Nasal SE Face Mask, Therapy Mask 3100 NC/SP
173
Total
169
Cleared
0
Denied
FDA 510(k) Regulatory Record - Respironics, Inc. Anesthesiology ✕
155 devices
Cleared
Sep 25, 2026
Altis Full Face Mask
Anesthesiology
162d
Cleared
Dec 30, 2024
AF531 Oro-Nasal SE Face Mask
Anesthesiology
60d
Cleared
Jul 28, 2023
Therapy Mask 3100 NC/SP
Anesthesiology
84d
Cleared
Aug 24, 2021
DreamWear Silicone Pillows Mask
Anesthesiology
155d
Cleared
Jul 12, 2021
Magneto Nasal Mask
Anesthesiology
153d
Cleared
Sep 25, 2020
Ventilator, Non-continuous (Respirator)
Anesthesiology
116d
Cleared
Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
Anesthesiology
134d
Cleared
Oct 18, 2019
Care Orchestrator Essence
Anesthesiology
332d
Cleared
CT
Oct 18, 2019
SomnaPatch
Anesthesiology
296d
Cleared
Jul 18, 2019
Trilogy Evo
Anesthesiology
442d
Cleared
Jul 18, 2019
Trilogy Evo Universal
Anesthesiology
442d
Cleared
Jan 04, 2019
Care Orchestrator
Anesthesiology
259d
Looking for a specific device from Respironics, Inc.? Search by device name or K-number.
Search all Respironics, Inc. devices