ClearanceBrief
Panels › Anesthesiology › Product code BZD · Class 2

Ventilator, Non-Continuous (Respirator)

Regulation 868.5905

12510(k)s in 12 months (463 all time)
3recalls in 12 months (83 all time)
79recalls that name a 510(k)
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Top companies in BZD

Company510(k)sRecalls
Resmed Corp979
Respironics, Inc.6825
Fisher & Paykel Healthcare Limited307
Sleepnet Corporation187
Apex Medical Corp.120
Philips Respironics110
3B Medical, Inc.91
Respironics Inc., Sleep & Home Respiratory Group100
Weinmann Gerate Fur Medizin GmbH + Co. KG90
Puritan Bennett Corp.80
Decided510(k)Device and applicantCode
Oct 23, 2026K260251BreathCare PAP III (YH-390N)
Suzhou Yuyue Medical Technology Co., Ltd., CN
BZD
Sep 25, 2026K261262Altis Full Face Mask
Respironics, Inc.
BZD
Jul 23, 2026K253044RXiBreeze PAP System (RXiBreeze 20C)
Resvent Medical Technology Co., Ltd., CN
BZD
Jun 4, 2026K253553Orion
Resmed Corp
BZD
May 27, 2026K254104ResScan Essentials
Resmed Corp
BZD
May 21, 2026K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
Dcstar, Inc.
BZD
Apr 29, 2026K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
BMC Medical Co., Ltd., CN
BZD
Apr 17, 2026K252338MySleepDash
Somnetics International, Inc. (Dba Transcend Inc)
BZD
Jan 15, 2026K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
Sleepnet Corporation
BZD
Jan 7, 2026K253939DeltaWave Nasal Pillow System
RemSleep Holdings, Inc.
BZD
Dec 15, 2025K251770SleepRes PAP System
Sleepres, Inc.
BZD
Dec 5, 2025K251657Personalized Therapy Comfort Settings (PTCS)
Resmed Corp
BZD
Jun 18, 2025K243583F&P Nova Nasal Mask
Fisher & Paykel Healthcare Limited, NZ
BZD
May 28, 2025K250624myAir
Resmed Corp
BZD
May 23, 2025K243023WiZARD 520 Full Face Mask
Wellell, Inc., TW
BZD
May 19, 2025K242547AirFit F20 Mask System; AirFit F20 NM Mask System
Resmed Pty , Ltd., AU
BZD
Jan 15, 2025K242935Respiration Data Management Software (PAP Link PC)
BMC Medical Co., Ltd., CN
BZD
Dec 31, 2024K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (
Genadyne Biotechnologies, Inc.
BZD
Oct 18, 2024K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
Sleepnet Corporation
BZD
Sep 27, 2024K241939EasyCare Tx 2
Resmed Corp
BZD
Sep 26, 2024K241216myAir
Resmed Corp
BZD
Sep 24, 2024K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
Resmed Pty Ltd (Registration Number: 3004604967), AU
BZD
Aug 23, 2024K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask
Fisher and Paykel Healthcare Limited, NZ
BZD
Jul 31, 2024K233555AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
Philips Respironics
BZD
Jul 10, 2024K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
Sleepnet Corporation
BZD
Jul 2, 2024K233415DELTAWAVE Nasal Pillows System
Remsleep Holdings
BZD
Jun 15, 2024K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
Sleepnet Corporation
BZD
Oct 19, 2023K230476Oran Park Mask
Resmed Pty Ltd (Registration Number: 3004604967), AU
BZD
Jul 28, 2023K231313Therapy Mask 3100 NC/SP
Respironics, Inc.
BZD
Jul 6, 2023K223747Whitsundays Mask System
Resmed Pty Ltd (Registration Number: 3004604967), AU
BZD
Jun 29, 2023K221436F&P 950 Accessory Breathing Circuit Kits
Fisher & Paykel Healthcare, Ltd., NZ
BZD
May 17, 2023K223696F&P Solo Mask Range
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Mar 25, 2022K212263Luna G3 BPAP System
3B Medical, Inc.
BZD
Mar 18, 2022K212371F&P Evora Full Face Mask
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Mar 9, 2022K211155Auto CPAP System
BMC Medical Co., Ltd., CN
BZD
Jan 10, 2022K211274iQ 2 Nasal Mask, Phantom 2 Nasal Mask
Sleepnet Corporation
BZD
Aug 24, 2021K210844DreamWear Silicone Pillows Mask
Respironics, Inc.
BZD
Jul 12, 2021K210386Magneto Nasal Mask
Respironics, Inc.
BZD
Jul 2, 2021K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask,
Suzhou Yuyue Medical Technology Co., Ltd., CN
BZD
Apr 30, 2021K203601Innova Nasal Non-Vented Mask
Sleepnet Corporation
BZD
Jan 29, 2021K201620Luna® G3 BPAP 25A
3B Medical, Inc.
BZD
Jan 17, 2021K200565Galapogos
Resmed Corp
BZD
Dec 18, 2020K203126S10 Kirra
Resmed Pty , Ltd., AU
BZD
Nov 25, 2020K192177SysMed S/T
Sysmed (China) Co., Ltd., CN
BZD
Oct 29, 2020K193206WiZARD 510 Nasal Mask
Apex Medical Corp., TW
BZD
Sep 25, 2020K201439Ventilator, Non-continuous (Respirator)
Respironics, Inc.
BZD
Jul 10, 2020K200480DreamStation 2 System, DreamStation 2 Advanced System
Respironics, Inc.
BZD
Jun 2, 2020K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Oct 18, 2019K183226Care Orchestrator Essence
Respironics, Inc.
BZD
Oct 11, 2019K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Larg
Fisher & Paykel Healthcare, Ltd., NZ
BZD

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