SOMNUM (SOMNUM)
FDA 510(k) clearance K253390 · decided 2026-06-27
Clearance details
- K-number
- K253390
- Device name
- SOMNUM (SOMNUM)
- Applicant
- Honeynaps Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-30
- Decision date
- 2026-06-27
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- OLZ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seoul, KR
- 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 |
|---|---|---|
| Onera SleepMap (SLEEPMAP) (K253668) | Onera B.V. | 2026-03-08 |
| Hypnos (369054-200) (K250851) | Cadwell Industries, Inc. | 2025-12-14 |
| DeepRESP (K252330) | Nox Medical Ehf | 2025-11-17 |
| NEAT 001 (K250058) | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 |
| DeepRESP (K241960) | Nox Medical Ehf | 2025-03-14 |
| Dreem 3S (K242094) | Beacon Biosignals, Inc. | 2024-11-22 |
| SleepStageML (K233438) | Beacon Biosignals, Inc. | 2024-03-08 |
| Dreem 3S (K223539) | Beacon Biosignals, Inc. | 2023-08-18 |
| SOMNUM (V.1.1.2.) (K223922) | Honeynaps Co., Ltd. | 2023-08-16 |
| SomnoMetry (K221179) | Neumetry Medical, Inc. | 2022-09-21 |
| EnsoSleep (K210034) | Ensodata, Inc. | 2021-06-16 |
| Sleepware G3 (K202142) | Respironics, Inc. | 2020-10-29 |
Recalls involving this device
No recalls on record reference this clearance.