FDA.report

Product code BZD

Current FDA Classification

Device name
Ventilator, Non-Continuous (Respirator)
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.5905
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.2026-04-29
K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)2026-04-17
K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation2026-01-15
K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.2026-01-07
K251770SleepRes PAP SystemSleepres, Inc.2025-12-15
K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp2025-12-05
K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited2025-06-18
K250624myAirResmed Corp2025-05-28
K243023WiZARD 520 Full Face MaskWellell, Inc.2025-05-23
K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty , Ltd.2025-05-19
K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.2025-01-15
K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)Genadyne Biotechnologies, Inc.2024-12-31
K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskSleepnet Corporation2024-10-18
K241939EasyCare Tx 2Resmed Corp2024-09-27
K241216myAirResmed Corp2024-09-26
K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)2024-09-24
K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)Fisher and Paykel Healthcare Limited2024-08-23
K233555AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face MaskPhilips Respironics2024-07-31
K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation2024-07-10
K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings2024-07-02
K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation2024-06-15
K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)2023-10-19
K231313Therapy Mask 3100 NC/SPRespironics, Inc.2023-07-28
K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)2023-07-06
K221436F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd.2023-06-29
K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.2023-05-17
K212263Luna G3 BPAP System3B Medical, Inc.2022-03-25
K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.2022-03-18
K211155Auto CPAP SystemBMC Medical Co., Ltd.2022-03-09
K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation2022-01-10

Related GUDID Devices

Primary DIBrandCompanyPublished
09420012464699Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED2026-03-19
04719893347258WellellWellell Inc.2026-03-17
04719893347265WellellWellell Inc.2026-03-17
04719893347272WellellWellell Inc.2026-03-17
44710810115620N/AGALEMED CORPORATION2026-03-05
44710810089747N/AGALEMED CORPORATION2026-03-05
24710810084946N/AGALEMED CORPORATION2026-03-05
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