Hypnos (369054-200)
FDA 510(k) K250851 · Cadwell Industries, Inc.
510(k) numberK250851
Submission
- Device name
- Hypnos (369054-200)
- Applicant
- Cadwell Industries, Inc.
Kennewick, WA, US - Received
- March 21, 2025
- Decision date
- December 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLZ – Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
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| K253390 | Somnum (Somnum)OLZ · Traditional | Honeynaps Co., Ltd. | 06/27/2026SE |
| K253668 | Onera SleepMap (SLEEPMAP)OLZ · Traditional | Onera B.V. | 03/08/2026SE |
| K252330 | DeepRESPOLZ · Traditional | Nox Medical Ehf | 11/17/2025SE |
| K250058 | Neat 001OLZ · Traditional | Brain Electrophysiology Laboratory Company, LLC | 04/10/2025SE |
| K241960 | DeepRESPOLZ · Traditional | Nox Medical Ehf | 03/14/2025SE |
| K242094 | Dreem 3SOLZ · Traditional | Beacon Biosignals, Inc. | 11/22/2024SE |
| K233438 | SleepStageMLOLZ · Traditional | Beacon Biosignals, Inc. | 03/08/2024SE |
| K223539 | Dreem 3SOLZ · Traditional | Beacon Biosignals, Inc. | 08/18/2023SE |
| K223922 | Somnum (V.1.1.2.)OLZ · Traditional | Honeynaps Co., Ltd. | 08/16/2023SE |
| K221179 | SomnoMetryOLZ · Traditional | Neumetry Medical, Inc. | 09/21/2022SE |
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Questions and answers
When was Hypnos (369054-200) cleared by the FDA?
Hypnos (369054-200) (K250851) received a 510(k) decision of Substantially Equivalent on December 14, 2025, 268 days after the submission was received.
What is the product code of K250851?
The FDA product code is OLZ – Automatic Event Detection Software For Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.