BZD · Ventilator, Non-Continuous (Respirator)
Anesthesiology · 21 CFR 868.5905 · Class 2
Overview
| Product Code | BZD |
|---|---|
| Device Name | Ventilator, Non-Continuous (Respirator) |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 456)
Showing 20 most recent of 456 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | Apr 17, 2026 | SESE |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | Jan 15, 2026 | SESE |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | Jan 7, 2026 | SESE |
| K251770 | SleepRes PAP System | Sleepres, Inc. | Dec 15, 2025 | SESE |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | Dec 5, 2025 | SESE |
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | Jun 18, 2025 | SESE |
| K250624 | myAir | Resmed Corp | May 28, 2025 | SESE |
| K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | May 23, 2025 | SESE |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | May 19, 2025 | SESE |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | Jan 15, 2025 | SESE |
| 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. | Dec 31, 2024 | SESE |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Sleepnet Corporation | Oct 18, 2024 | SESE |
| K241939 | EasyCare Tx 2 | Resmed Corp | Sep 27, 2024 | SESE |
| K241216 | myAir | Resmed Corp | Sep 26, 2024 | SESE |
| K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | Sep 24, 2024 | SESE |
| 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 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 Limited | Aug 23, 2024 | SESE |
| K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | Philips Respironics | Jul 31, 2024 | SESE |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Sleepnet Corporation | Jul 10, 2024 | SESE |
| K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings | Jul 2, 2024 | SESE |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation | Jun 15, 2024 | SESE |
Top Applicants
- Resmed, Ltd. — 81 clearances
- Respironics, Inc. — 67 clearances
- Fisher & Paykel Healthcare, Ltd. — 25 clearances
- Sleepnet Corporation — 18 clearances
- Apex Medical Corp. — 12 clearances
