Luna G3 BPAP System
FDA 510(k) K212263 · 3B Medical, Inc.
510(k) numberK212263
Submission
- Device name
- Luna G3 BPAP System
- Applicant
- 3B Medical, Inc.
Winter, FL, US - Received
- July 20, 2021
- Decision date
- March 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C)BZD · Traditional | Resvent Medical Technology Co., Ltd. | 07/23/2026SE |
| K253553 | OrionBZD · Traditional | Resmed Corp | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | Resmed Corp | 05/27/2026SE |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…BZD · Traditional | Dcstar, Inc. | 05/21/2026SE |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZD · Traditional | BMC Medical Co., Ltd. | 04/29/2026SE |
| K252338 | MySleepDashBZD · Traditional | Somnetics International, Inc. (Dba Transcend Inc) | 04/17/2026SE |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | Resmed Corp | 12/05/2025SE |
More from Resmed Corp
| 510(k) | Device | Decision |
|---|---|---|
| K201620 | Luna® G3 BPAP 25ABZD · Traditional | 01/29/2021SE |
| K200496 | Aer XCAW · Special | 07/24/2020SE |
| K160127 | iCodeConnectBZD · Traditional | 11/10/2016SE |
| K153387 | Luna CPAP and Auto CPAP SystemBZD · Traditional | 09/08/2016SE |
| K141770 | Luna CPAP and Auto-Cpap SystemBZD · Traditional | 04/22/2015SE |
| K133769 | 3B Resmart Bpap 25A, BMC Resmart Bpap 25ABZD · Traditional | 08/25/2014SE |
| K131901 | Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2BZD · Traditional | 12/23/2013SE |
| K132967 | 3B Resmart CPAP and Auto CPAP, BMC Resmart CPAP and Auto CPAPBZD · Special | 12/06/2013SE |
| K131707 | 3B Resmart CPAP and Auto CPAP Systems, BMC Resmart CPAP and Auto CPAP SystemsBZD · Special | 08/22/2013SE |
Questions and answers
When was Luna G3 BPAP System cleared by the FDA?
Luna G3 BPAP System (K212263) received a 510(k) decision of Substantially Equivalent on March 25, 2022, 248 days after the submission was received.
What is the product code of K212263?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.