Product code BZD
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| K253553 | Orion | Resmed Corp | 2026-06-04 |
| K254104 | ResScan Essentials | Resmed Corp | 2026-05-27 |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | 2026-05-21 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026-04-29 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026-01-15 |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 2026-01-07 |
| K251770 | SleepRes PAP System | Sleepres, Inc. | 2025-12-15 |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | 2025-12-05 |
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| K250624 | myAir | Resmed Corp | 2025-05-28 |
| K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | 2025-05-23 |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | 2025-05-19 |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | 2025-01-15 |
| K243225 | Nasal 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 |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Sleepnet Corporation | 2024-10-18 |
| K241939 | EasyCare Tx 2 | Resmed Corp | 2024-09-27 |
| K241216 | myAir | Resmed Corp | 2024-09-26 |
| K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2024-09-24 |
| K233829 | Nova 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... | Fisher and Paykel Healthcare Limited | 2024-08-23 |
| K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | Philips Respironics | 2024-07-31 |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Sleepnet Corporation | 2024-07-10 |
| K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings | 2024-07-02 |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation | 2024-06-15 |
| K230476 | Oran Park Mask | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 |
| K231313 | Therapy Mask 3100 NC/SP | Respironics, Inc. | 2023-07-28 |
| K223747 | Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 |
| K223696 | F&P Solo Mask Range | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344011858 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011964 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011957 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011940 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011933 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011926 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011919 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011902 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011896 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011889 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011872 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 10197344011865 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2026-08-27 |
| 00848530109684 | CPAP Mask Kit | SUNSET HEALTHCARE SOLUTIONS, INC. | 2026-08-15 |
| 00848530109677 | CPAP Mask Kit | SUNSET HEALTHCARE SOLUTIONS, INC. | 2026-08-15 |
| 00198843003620 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 06970819423212 | RXiBreeze PAP System | Resvent Medical Technology Co., Ltd. | 2026-08-14 |
| 00198843003699 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003682 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003675 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003668 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003651 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003644 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003637 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003613 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 00198843003606 | Infant Flow™ | Zoll Medical Corporation | 2026-08-14 |
| 04048675824121 | Seattle PAP | Drägerwerk AG & Co. KGaA | 2026-06-11 |
| 04713025000820 | Wellell | Wellell Inc. | 2025-05-28 |
| 04713025000837 | Wellell | Wellell Inc. | 2025-05-28 |
| 06948538362563 | Water Chamber | BMC Medical Co., Ltd. | 2022-08-29 |
| 10884527007110 | Argyle | Cardinal Health, Inc. | 2016-09-24 |