Cleared Traditional

K831127 - INTRA-ORAL ARTIFICIAL LARYNX (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K831127 · Xomed, Inc. · Ear, Nose, Throat device
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Jul 1983
Decision
113d
Days
Class 1
Risk

K831127 is an FDA 510(k) clearance for the INTRA-ORAL ARTIFICIAL LARYNX. Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 113 days - within the typical 510(k) review window.

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 Xomed, Inc. devices

Submission Details

510(k) Number K831127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1983
Decision Date July 28, 1983
Days to Decision 113 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 89d · This submission: 113d
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.