Cleared Traditional

AMERICAN ARTIFICIAL LARYNX (K914816) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K914816 · Ultravoice, Ltd. · Ear, Nose, Throat device
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Feb 1993
Decision
476d
Days
Class 1
Risk

K914816 is an FDA 510(k) clearance for the AMERICAN ARTIFICIAL LARYNX. Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Ultravoice, Ltd. (Paoli, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Ultravoice, Ltd. devices

Submission Details

510(k) Number K914816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date February 12, 1993
Days to Decision 476 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
387d slower than avg
Panel avg: 89d · This submission: 476d
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.