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/productcode/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 460)

Showing 20 most recent of 460 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253553](/device/K253553.md) | Orion | Resmed Corp | Jun 4, 2026 | SESE |
| [K254104](/device/K254104.md) | ResScan Essentials | Resmed Corp | May 27, 2026 | SESE |
| [K251920](/device/K251920.md) | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | May 21, 2026 | SESE |
| [K253166](/device/K253166.md) | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | Apr 29, 2026 | SESE |
| [K252338](/device/K252338.md) | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | Apr 17, 2026 | SESE |
| [K251847](/device/K251847.md) | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | Jan 15, 2026 | SESE |
| [K253939](/device/K253939.md) | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | Jan 7, 2026 | SESE |
| [K251770](/device/K251770.md) | SleepRes PAP System | Sleepres, Inc. | Dec 15, 2025 | SESE |
| [K251657](/device/K251657.md) | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | Dec 5, 2025 | SESE |
| [K243583](/device/K243583.md) | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | Jun 18, 2025 | SESE |
| [K250624](/device/K250624.md) | myAir | Resmed Corp | May 28, 2025 | SESE |
| [K243023](/device/K243023.md) | WiZARD 520 Full Face Mask | Wellell, Inc. | May 23, 2025 | SESE |
| [K242547](/device/K242547.md) | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | May 19, 2025 | SESE |
| [K242935](/device/K242935.md) | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | Jan 15, 2025 | SESE |
| [K243225](/device/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](/device/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](/device/K241939.md) | EasyCare Tx 2 | Resmed Corp | Sep 27, 2024 | SESE |
| [K241216](/device/K241216.md) | myAir | Resmed Corp | Sep 26, 2024 | SESE |
| [K234134](/device/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](/device/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 |

## Top Applicants

- Resmed, Ltd. — 81 clearances
- Respironics, Inc. — 67 clearances
- Fisher & Paykel Healthcare, Ltd. — 25 clearances
- Sleepnet Corporation — 18 clearances
- Resmed Corp — 14 clearances

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**Source:** [https://fda.innolitics.com/productcode/BZD](https://fda.innolitics.com/productcode/BZD)

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