SleepRes PAP System
FDA 510(k) clearance K251770 · decided 2025-12-15
Clearance details
- K-number
- K251770
- Device name
- SleepRes PAP System
- Applicant
- Sleepres, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-10
- Decision date
- 2025-12-15
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murfreesboro, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RXiBreeze PAP System (RXiBreeze 20C) (K253044) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| Orion (K253553) | Resmed Corp | 2026-06-04 |
| ResScan Essentials (K254104) | Resmed Corp | 2026-05-27 |
| Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (K251920) | Dcstar, Inc. | 2026-05-21 |
| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) | BMC Medical Co., Ltd. | 2026-04-29 |
| MySleepDash (K252338) | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (K251847) | Sleepnet Corporation | 2026-01-15 |
| DeltaWave Nasal Pillow System (K253939) | RemSleep Holdings, Inc. | 2026-01-07 |
| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
| F&P Nova Nasal Mask (K243583) | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| myAir (K250624) | Resmed Corp | 2025-05-28 |
| WiZARD 520 Full Face Mask (K243023) | Wellell, Inc. | 2025-05-23 |
Recalls involving this device
No recalls on record reference this clearance.