Cleared Traditional

K912817 - SOMNIMIC (R) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912817 · Somnitec, Inc. · Neurology device
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Jul 1991
Decision
66d
Days
Class 2
Risk

K912817 is an FDA 510(k) clearance for the SOMNIMIC (R). Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Somnitec, Inc. (San Francisco, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Somnitec, Inc. devices

Submission Details

510(k) Number K912817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date July 26, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 148d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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.

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All 18
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