BZD — Ventilator, Non-Continuous (Respirator) Class II
FDA product code BZD covers "Ventilator, Non-Continuous (Respirator)", a Class II medical device regulated under 21 CFR 868.5905. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253553 | resmed | Orion | June 4, 2026 |
| K254104 | resmed | ResScan Essentials | May 27, 2026 |
| K251920 | dcstar | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Ful | May 21, 2026 |
| K253166 | bmc medical co | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | April 29, 2026 |
| K252338 | somnetics international, inc. (dba transcend inc) | MySleepDash | April 17, 2026 |
| 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 |