Cleared Traditional

K201054 - SOMNOscreen plus

K201054 is an FDA 510(k) clearance for SOMNOscreen plus, manufactured by Somnomedics GmbH. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K201054 · Somnomedics GmbH · Neurology device
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Aug 2020
Decision
113d
Days
Class 2
Risk

K201054 is an FDA 510(k) clearance for the SOMNOscreen plus. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on August 12, 2020 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Somnomedics GmbH devices

FDA 510(k) Submission Details - K201054

510(k) Number K201054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date August 12, 2020
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLV Device Classification - Class 2, Special Controls

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLV Standard Polysomnograph With Electroencephalograph

All 27
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