Cleared Traditional

DENRICK SPEECH AID (DR-1) (K931371) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K931371 · Denrick Corp. · Ear, Nose, Throat device
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Aug 1993
Decision
161d
Days
Class 1
Risk

K931371 is an FDA 510(k) clearance for the DENRICK SPEECH AID (DR-1). Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Denrick Corp. (Honolulu, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 161 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3375 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Denrick Corp. devices

Submission Details

510(k) Number K931371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date August 25, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 89d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESE Larynx, Artificial (battery-powered)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.