BZD
- Product code
- BZD
- Device name
- Ventilator, Non-Continuous (Respirator)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5905
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 26
- Summaries archived here
- 23 (direct download)
- 510(k) clearances (all years, FDA)
- 461 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (26)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253044 | 2026-07-23 | Resvent Medical Technology Co., Ltd. | RXiBreeze PAP System (RXiBreeze 20C) | |
| K253553 | 2026-06-04 | Resmed Corp | Orion | |
| K254104 | 2026-05-27 | Resmed Corp | ResScan Essentials | FDA |
| K251920 | 2026-05-21 | Dcstar, Inc. | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full… | |
| K253166 | 2026-04-29 | BMC Medical Co., Ltd. | F6S Full Face Mask (F6S); P6S Nasal Pillows Interfac… | |
| K252338 | 2026-04-17 | Somnetics International, Inc. (Dba Tra… | MySleepDash | |
| K251847 | 2026-01-15 | Sleepnet Corporation | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie N… | |
| K253939 | 2026-01-07 | RemSleep Holdings, Inc. | DeltaWave Nasal Pillow System | |
| K251770 | 2025-12-15 | Sleepres, Inc. | SleepRes PAP System | |
| K251657 | 2025-12-05 | Resmed Corp | Personalized Therapy Comfort Settings (PTCS) | |
| K243583 | 2025-06-18 | Fisher & Paykel Healthcare Limited | F&P Nova Nasal Mask | |
| K250624 | 2025-05-28 | Resmed Corp | myAir | |
| K243023 | 2025-05-23 | Wellell, Inc. | WiZARD 520 Full Face Mask | |
| K242547 | 2025-05-19 | Resmed Pty , Ltd. | AirFit F20 Mask System; AirFit F20 NM Mask System | |
| K242935 | 2025-01-15 | BMC Medical Co., Ltd. | Respiration Data Management Software (PAP Link PC) | |
| K243225 | 2024-12-31 | Genadyne Biotechnologies, Inc. | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal … | |
| K241830 | 2024-10-18 | Sleepnet Corporation | Mojo Full Face Vented Mask; Veraseal 2 Full Face Ven… | |
| K241939 | 2024-09-27 | Resmed Corp | EasyCare Tx 2 | |
| K241216 | 2024-09-26 | Resmed Corp | myAir | |
| K234134 | 2024-09-24 | Resmed Pty Ltd (Registration Number: 3… | AirFit F30i Mask System; AirFit F30i NM Mask System;… | |
| K233829 | 2024-08-23 | Fisher and Paykel Healthcare Limited | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova… | |
| K233555 | 2024-07-31 | Philips Respironics | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal… | FDA |
| K241661 | 2024-07-10 | Sleepnet Corporation | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face V… | FDA |
| K233415 | 2024-07-02 | Remsleep Holdings | DELTAWAVE Nasal Pillows System | |
| K241469 | 2024-06-15 | Sleepnet Corporation | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | |
| K230476 | 2023-10-19 | Resmed Pty Ltd (Registration Number: 3… | Oran Park Mask |
Official FDA classification page: BZD
Classification and pathway per current FDA publications. Data from openFDA (CC0).