BZD — Ventilator, Non-Continuous (Respirator) Class II
FDA Device Classification
Classification Details
- Product Code
- BZD
- Device Class
- Class II
- Regulation Number
- 868.5905
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251847 | sleepnet corporation | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | January 15, 2026 |
| K253939 | remsleep holdings | DeltaWave Nasal Pillow System | January 7, 2026 |
| K251770 | sleepres | SleepRes PAP System | December 15, 2025 |
| K251657 | resmed | Personalized Therapy Comfort Settings (PTCS) | December 5, 2025 |
| K243583 | fisher and paykel healthcare limited | F&P Nova Nasal Mask | June 18, 2025 |
| K250624 | resmed | myAir | May 28, 2025 |
| K243023 | wellell | WiZARD 520 Full Face Mask | May 23, 2025 |
| K242547 | resmed pty | AirFit F20 Mask System; AirFit F20 NM Mask System | May 19, 2025 |
| K242935 | bmc medical co | Respiration Data Management Software (PAP Link PC) | January 15, 2025 |
| K243225 | genadyne biotechnologies | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 | December 31, 2024 |
| K241830 | sleepnet corporation | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face V | October 18, 2024 |
| K241939 | resmed | EasyCare Tx 2 | September 27, 2024 |
| K241216 | resmed | myAir | September 26, 2024 |
| K234134 | resmed pty ltd (registration number: 3004604967) | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | September 24, 2024 |
| K233829 | fisher and paykel healthcare limited | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A | August 23, 2024 |
| K233555 | philips respironics | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | July 31, 2024 |
| K241661 | sleepnet corporation | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Ven | July 10, 2024 |
| K233415 | remsleep holdings | DELTAWAVE Nasal Pillows System | July 2, 2024 |
| K241469 | sleepnet corporation | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | June 15, 2024 |
| K230476 | resmed pty ltd (registration number: 3004604967) | Oran Park Mask | October 19, 2023 |