Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
FDA 510(k) K243225 · Genadyne Biotechnologies, Inc.
510(k) numberK243225
Submission
- Device name
- Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
- Applicant
- Genadyne Biotechnologies, Inc.
Hicksville, NY, US - Received
- October 8, 2024
- Decision date
- December 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
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| K253429 | Genadyne ASTRA NPWTOMP · Traditional | 03/12/2026SE |
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| K221891 | UNO Negative Pressure Wound Therapy SystemOMP · Special | 12/14/2022SE |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP · Traditional | 06/01/2022SE |
| K190028 | Uno 30OMP · Traditional | 01/15/2020SE |
| K182722 | XLR8 Abdominal Wound Dressing KitOMP · Traditional | 09/27/2019SE |
| K180840 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | 11/30/2018SE |
| K161599 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | 04/06/2017SE |
| K143726 | XLR8 Plus (XLR8+)OMP · Traditional | 06/19/2015SE |
Questions and answers
When was Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) cleared by the FDA?
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (K243225) received a 510(k) decision of Substantially Equivalent on December 31, 2024, 84 days after the submission was received.
What is the product code of K243225?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.