BZD · Class II · 21 CFR 868.5905

FDA Product Code BZD: Ventilator, Non-continuous (respirator)

FDA product code BZD covers non-continuous ventilators, also known as intermittent positive pressure breathing (IPPB) devices and home respiratory support equipment.

Unlike continuous ventilators, these devices deliver assisted breaths only when triggered by the patient or on an intermittent schedule. They are used for the treatment of chronic respiratory conditions, post-operative respiratory therapy, and as backup support for patients with mild ventilatory insufficiency.

BZD devices are Class II medical devices, regulated under 21 CFR 868.5905 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Respironics, Inc., Sleepnet Corporation and ResMed Corp.

460
Total
460
Cleared
155d
Avg days
1977
Since
460 devices
25–48 of 460
Cleared Oct 19, 2023
Oran Park Mask
K230476
Resmed Pty Ltd (Registration Number: 3004604967)
Anesthesiology · 239d
Cleared Jul 28, 2023
Therapy Mask 3100 NC/SP
K231313
Respironics, Inc.
Anesthesiology · 84d
Cleared Jul 06, 2023
Whitsundays Mask System
K223747
Resmed Pty Ltd (Registration Number: 3004604967)
Anesthesiology · 204d
Cleared Jun 29, 2023
F&P 950 Accessory Breathing Circuit Kits
K221436
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 408d
Cleared May 17, 2023
F&P Solo Mask Range
K223696
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 159d
Cleared Mar 25, 2022
Luna G3 BPAP System
K212263
3B Medical, Inc.
Anesthesiology · 248d
Cleared Mar 18, 2022
F&P Evora Full Face Mask
K212371
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Mar 09, 2022
Auto CPAP System
K211155
BMC Medical Co., Ltd.
Anesthesiology · 324d
Cleared Jan 10, 2022
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
K211274
Sleepnet Corporation
Anesthesiology · 258d
Cleared Aug 24, 2021
DreamWear Silicone Pillows Mask
K210844
Respironics, Inc.
Anesthesiology · 155d
Cleared Jul 12, 2021
Magneto Nasal Mask
K210386
Respironics, Inc.
Anesthesiology · 153d
Cleared Jul 02, 2021
Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
K203347
Suzhou Yuyue Medical Technology Co., Ltd.
Anesthesiology · 231d
Cleared Apr 30, 2021
Innova Nasal Non-Vented Mask
K203601
Sleepnet Corporation
Anesthesiology · 142d
Cleared Jan 29, 2021
Luna® G3 BPAP 25A
K201620
3B Medical, Inc.
Anesthesiology · 228d
Cleared Jan 17, 2021
Galapogos
K200565
ResMed Corp
Anesthesiology · 319d
Cleared Dec 18, 2020
S10 Kirra
K203126
Resmed Pty , Ltd.
Anesthesiology · 60d
Cleared Nov 25, 2020
SysMed S/T
K192177
Sysmed (China) Co., Ltd.
Anesthesiology · 471d
Cleared Oct 29, 2020
WiZARD 510 Nasal Mask
K193206
Apex Medical Corp.
Anesthesiology · 344d
Cleared Sep 25, 2020
Ventilator, Non-continuous (Respirator)
K201439
Respironics, Inc.
Anesthesiology · 116d
Cleared Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
K200480
Respironics, Inc.
Anesthesiology · 134d
Cleared Jun 02, 2020
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
K200089
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Oct 18, 2019
Care Orchestrator Essence
K183226
Respironics, Inc.
Anesthesiology · 332d
Cleared Oct 11, 2019
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
K190713
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Jul 05, 2019
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
K190254
Sleepnet Corporation
Anesthesiology · 148d