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
Cleared
Oct 19, 2023
Oran Park Mask
Resmed Pty Ltd (Registration Number: 3004604967)
Anesthesiology
239d
Cleared
Jul 28, 2023
Therapy Mask 3100 NC/SP
Respironics, Inc.
Anesthesiology
84d
Cleared
Jul 06, 2023
Whitsundays Mask System
Resmed Pty Ltd (Registration Number: 3004604967)
Anesthesiology
204d
Cleared
Jun 29, 2023
F&P 950 Accessory Breathing Circuit Kits
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
408d
Cleared
May 17, 2023
F&P Solo Mask Range
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
159d
Cleared
Mar 25, 2022
Luna G3 BPAP System
3B Medical, Inc.
Anesthesiology
248d
Cleared
Mar 18, 2022
F&P Evora Full Face Mask
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
231d
Cleared
Mar 09, 2022
Auto CPAP System
BMC Medical Co., Ltd.
Anesthesiology
324d
Cleared
Jan 10, 2022
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
Sleepnet Corporation
Anesthesiology
258d
Cleared
Aug 24, 2021
DreamWear Silicone Pillows Mask
Respironics, Inc.
Anesthesiology
155d
Cleared
Jul 12, 2021
Magneto Nasal Mask
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
Suzhou Yuyue Medical Technology Co., Ltd.
Anesthesiology
231d
Cleared
Apr 30, 2021
Innova Nasal Non-Vented Mask
Sleepnet Corporation
Anesthesiology
142d
Cleared
Jan 29, 2021
Luna® G3 BPAP 25A
3B Medical, Inc.
Anesthesiology
228d
Cleared
Jan 17, 2021
Galapogos
ResMed Corp
Anesthesiology
319d
Cleared
Dec 18, 2020
S10 Kirra
Resmed Pty , Ltd.
Anesthesiology
60d
Cleared
Nov 25, 2020
SysMed S/T
Sysmed (China) Co., Ltd.
Anesthesiology
471d
Cleared
Oct 29, 2020
WiZARD 510 Nasal Mask
Apex Medical Corp.
Anesthesiology
344d
Cleared
Sep 25, 2020
Ventilator, Non-continuous (Respirator)
Respironics, Inc.
Anesthesiology
116d
Cleared
Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
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
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
139d
Cleared
Oct 18, 2019
Care Orchestrator Essence
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)
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
Sleepnet Corporation
Anesthesiology
148d