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
Growing category - 23 submissions in the last 2 years vs 6 in the prior period
Review times increasing: avg 184d recently vs 153d historically

FDA 510(k) Cleared Ventilator, Non-continuous (respirator) Devices (Product Code BZD)

460 devices
1–24 of 460
Cleared Jun 04, 2026
Orion
K253553
ResMed Corp
Anesthesiology · 202d
Cleared May 27, 2026
ResScan Essentials
K254104
ResMed Corp
Anesthesiology · 159d
Cleared May 21, 2026
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
K251920
Dcstar, Inc.
Anesthesiology · 332d
Cleared Apr 29, 2026
F6S Full Face Mask (F6S)
K253166
BMC Medical Co., Ltd.
Anesthesiology · 215d
Cleared Apr 17, 2026
MySleepDash
K252338
Somnetics International, Inc. (Dba Transcend Inc)
Anesthesiology · 263d
Cleared Jan 15, 2026
Sleepnet Arie Full Face Vented Mask
K251847
Sleepnet Corporation
Anesthesiology · 213d
Cleared Jan 07, 2026
DeltaWave Nasal Pillow System
K253939
RemSleep Holdings, Inc.
Anesthesiology · 29d
Cleared Dec 15, 2025
SleepRes PAP System
K251770
Sleepres, Inc.
Anesthesiology · 188d
Cleared Dec 05, 2025
Personalized Therapy Comfort Settings (PTCS)
K251657
ResMed Corp
Anesthesiology · 189d
Cleared Jun 18, 2025
F&P Nova Nasal Mask
K243583
Fisher & Paykel Healthcare Limited
Anesthesiology · 210d
Cleared May 28, 2025
myAir
K250624
ResMed Corp
Anesthesiology · 86d
Cleared May 23, 2025
WiZARD 520 Full Face Mask
K243023
Wellell, Inc.
Anesthesiology · 238d
Cleared May 19, 2025
AirFit F20 Mask System
K242547
Resmed Pty , Ltd.
Anesthesiology · 265d
Cleared Jan 15, 2025
Respiration Data Management Software (PAP Link PC)
K242935
BMC Medical Co., Ltd.
Anesthesiology · 112d
Cleared Dec 31, 2024
Nasal Pillow Mask - Small (NNPM-01/ Nefes S)
K243225
Genadyne Biotechnologies, Inc.
Anesthesiology · 84d
Cleared Oct 18, 2024
Mojo Full Face Vented Mask
K241830
Sleepnet Corporation
Anesthesiology · 116d
Cleared Sep 27, 2024
EasyCare Tx 2
K241939
ResMed Corp
Anesthesiology · 87d
Cleared Sep 26, 2024
myAir
K241216
ResMed Corp
Anesthesiology · 148d
Cleared Sep 24, 2024
AirFit F30i Mask System
K234134
Resmed Pty Ltd (Registration Number: 3004604967)
Anesthesiology · 270d
Cleared Aug 23, 2024
Nova Micro Pillows Mask Small A Model (NVP1SA)
K233829
Fisher and Paykel Healthcare Limited
Anesthesiology · 266d
Cleared Jul 31, 2024
AF531 Oro-Nasal EE Leak 1 Face Mask
K233555
Philips Respironics
Anesthesiology · 268d
Cleared Jul 10, 2024
Mojo 2 Full Face Vented Mask
K241661
Sleepnet Corporation
Anesthesiology · 30d
Cleared Jul 02, 2024
DELTAWAVE Nasal Pillows System
K233415
Remsleep Holdings
Anesthesiology · 266d
Cleared Jun 15, 2024
iQ 2 Nasal Vented Mask
K241469
Sleepnet Corporation
Anesthesiology · 22d

About Product Code BZD - Regulatory Context

510(k) Submission Activity

460 total 510(k) submissions under product code BZD since 1977, with 460 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 23 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BZD Product Code

Recent submissions under BZD have taken an average of 184 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.

BZD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →