WiZARD 310/320 Series CPAP Mask
FDA 510(k) K182394 · Apex Medical Corp.
510(k) numberK182394
Submission
- Device name
- WiZARD 310/320 Series CPAP Mask
- Applicant
- Apex Medical Corp.
New Taipei City, TW - Received
- September 4, 2018
- Decision date
- May 17, 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
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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 |
|---|---|---|
| K213577 | VenAir, Sequential Compression SystemJOW · Traditional | 06/28/2022SE |
| K193206 | WiZARD 510 Nasal MaskBZD · Traditional | 10/29/2020SE |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesBZD · Traditional | 09/15/2015SE |
| K141522 | Apex Medical Corp. Ich CPAP with Pva 9S-007XXX SeriesBZD · Traditional | 10/06/2014SE |
| K121642 | Wizard 230 Nasal Pilow MaskBZD · Traditional | 06/06/2013SE |
| K112079 | Apex Medical XT Auto CPAP with Compliance Improvement Algorithm 9S-005720BZD · Traditional | 12/06/2012SE |
| K120035 | Apex Medical Ich CPAP Series (9S-007XXX)BZD · Special | 05/16/2012SE |
| K103174 | Apex Medical Wizard Series CPAP MaskBZD · Traditional | 05/06/2011SE |
| K103535 | Vacplus Suction UnitJCX · Traditional | 02/24/2011SE |
| K083656 | Apex Medical XT Auto CPAP 9S-005200BZD · Traditional | 04/22/2009SE |
Questions and answers
When was WiZARD 310/320 Series CPAP Mask cleared by the FDA?
WiZARD 310/320 Series CPAP Mask (K182394) received a 510(k) decision of Substantially Equivalent on May 17, 2019, 255 days after the submission was received.
What is the product code of K182394?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.