Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
FDA 510(k) K190254 · Sleepnet Corporation
510(k) numberK190254
Submission
- Device name
- Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
- Applicant
- Sleepnet Corporation
Hampton, NH, US - Received
- February 7, 2019
- Decision date
- July 5, 2019
- 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
Other 510(k)s with product code BZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | 01/15/2026SE |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…BZD · Traditional | 10/18/2024SE |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full…CBK · Traditional | 08/28/2024SE |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskBZD · Special | 07/10/2024SE |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…CBK · Special | 06/27/2024SE |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskBZD · Special | 06/15/2024SE |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal MaskBZD · Traditional | 01/10/2022SE |
| K203601 | Innova Nasal Non-Vented MaskBZD · Traditional | 04/30/2021SE |
| K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…CBK · Traditional | 07/26/2019SE |
| K121321 | Hard Shell Vented Nasal MaskBZD · Traditional | 11/30/2012SE |
Questions and answers
When was Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask cleared by the FDA?
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask (K190254) received a 510(k) decision of Substantially Equivalent on July 5, 2019, 148 days after the submission was received.
What is the product code of K190254?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.