Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5905](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5905) → BZD — Ventilator, Non-Continuous (Respirator) # BZD · Ventilator, Non-Continuous (Respirator) _Anesthesiology · 21 CFR 868.5905 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD ## Overview - **Product Code:** BZD - **Device Name:** Ventilator, Non-Continuous (Respirator) - **Regulation:** [21 CFR 868.5905](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5905) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K252338.md) | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | Apr 17, 2026 | SESE | | [K251847](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K251847.md) | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | Jan 15, 2026 | SESE | | [K253939](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K253939.md) | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | Jan 7, 2026 | SESE | | [K251770](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K251770.md) | SleepRes PAP System | Sleepres, Inc. | Dec 15, 2025 | SESE | | [K251657](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K251657.md) | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | Dec 5, 2025 | SESE | | [K243583](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K243583.md) | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | Jun 18, 2025 | SESE | | [K250624](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K250624.md) | myAir | Resmed Corp | May 28, 2025 | SESE | | [K243023](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K243023.md) | WiZARD 520 Full Face Mask | Wellell, Inc. | May 23, 2025 | SESE | | [K242547](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K242547.md) | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | May 19, 2025 | SESE | | [K242935](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K242935.md) | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | Jan 15, 2025 | SESE | | [K243225](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K243225.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K241830.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K241939.md) | EasyCare Tx 2 | Resmed Corp | Sep 27, 2024 | SESE | | [K241216](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K241216.md) | myAir | Resmed Corp | Sep 26, 2024 | SESE | | [K234134](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K234134.md) | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | Sep 24, 2024 | SESE | | [K233829](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K233829.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K233555.md) | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | Philips Respironics | Jul 31, 2024 | SESE | | [K241661](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K241661.md) | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Sleepnet Corporation | Jul 10, 2024 | SESE | | [K233415](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K233415.md) | DELTAWAVE Nasal Pillows System | Remsleep Holdings | Jul 2, 2024 | SESE | | [K241469](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K241469.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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