DreamWear Silicone Pillows Mask
FDA 510(k) K210844 · Respironics, Inc.
510(k) numberK210844
Submission
- Device name
- DreamWear Silicone Pillows Mask
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- March 22, 2021
- Decision date
- August 24, 2021
- 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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| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
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| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
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More from Resmed Corp
| 510(k) | Device | Decision |
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| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | 12/30/2024SE |
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| K210386 | Magneto Nasal MaskBZD · Traditional | 07/12/2021SE |
| K202142 | Sleepware G3OLZ · Traditional | 10/29/2020SE |
| K201439 | Ventilator, Non-continuous (Respirator)BZD · Traditional | 09/25/2020SE |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced SystemBZD · Traditional | 07/10/2020SE |
| K183625 | SomnaPatchMNR · Traditional | 10/18/2019SE |
| K183226 | Care Orchestrator EssenceBZD · Traditional | 10/18/2019SE |
| K181170 | Trilogy Evo UniversalCBK · Traditional | 07/18/2019SE |
| K181166 | Trilogy EvoCBK · Traditional | 07/18/2019SE |
Questions and answers
When was DreamWear Silicone Pillows Mask cleared by the FDA?
DreamWear Silicone Pillows Mask (K210844) received a 510(k) decision of Substantially Equivalent on August 24, 2021, 155 days after the submission was received.
What is the product code of K210844?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.