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 |
|---|---|---|---|
| K260251 | BreathCare PAP III (YH-390N) | Suzhou Yuyue Medical Technology Co., Ltd. | 2026-10-23 |
| K261262 | Altis Full Face Mask | Respironics, Inc. | 2026-09-25 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00814747025154 | Ascend Nasal Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025376 | Novaplus Hospital Nasal Vented Mask, m/l | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025369 | Novaplus Hospital Nasal Non Vented Mask, s/m | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025352 | Novaplus Hospital Nasal Non Vented Mask, m/l | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025345 | Novaplus Full Face Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025338 | Novaplus Full Face Vented Mask, Medium | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025321 | Novaplus Full Face Vented Mask, Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025314 | Novaplus Full Face Vented Mask, Extra Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025222 | MiniMe 2 Pediatric Nasal Vented Mask, Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025215 | MiniMe 2 Pediatric Nasal Vented Mask, Medium | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025208 | MiniMe 2 Pediatric Nasal Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025192 | MiniMe 2 Pediatric Nasal Vented Mask, Extra Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025185 | Phantom 2 Nasal Vented Mask | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025178 | IQ 2 Nasal Mask | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025161 | Ascend Nasal Vented Mask, Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025147 | Ascend Nasal Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025130 | Ascend Nasal Vented Mask Kit | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025123 | Arie Nasal Vented Mask, Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025116 | Arie Nasal Vented Mask, Medium | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025109 | Arie Nasal Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025093 | Arie Nasal Vented Mask Kit | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025086 | Ascend Full Face Vented Mask, Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025079 | Ascend Full Face Vented Mask, Medium | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025062 | Ascend Full Face Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025055 | Ascend Full Face Vented Mask Kit | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025048 | Arie Full Face Vented Mask, Large | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025031 | Arie Full Face Vented Mask, Medium | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025024 | Arie Full Face Vented Mask, Small | SLEEPNET, CORP. | 2026-10-23 |
| 00814747025017 | Arie Full Face Vented Mask Kit | SLEEPNET, CORP. | 2026-10-23 |
| 00810094575977 | Curaplex | BOUND TREE MEDICAL, LLC | 2023-06-30 |