Sleep Profiler
FDA 510(k) clearance K153412 · decided 2016-03-14
Clearance details
- K-number
- K153412
- Device name
- Sleep Profiler
- Applicant
- Advanced Brain Monitoring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-25
- Decision date
- 2016-03-14
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- OLZ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Advanced Brain Monitoring
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SOMNUM (SOMNUM) (K253390) | Honeynaps Co., Ltd. | 2026-06-27 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.