Cleared Traditional

K831127 - INTRA-ORAL ARTIFICIAL LARYNX

K831127 is an FDA 510(k) clearance for INTRA-ORAL ARTIFICIAL LARYNX, manufactured by Xomed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K831127

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 90d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

ESE Device Classification - Class 1, General Controls

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.