Cleared Traditional

NORTHWESTERN VOICE RESTORATION KIT (K811428) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K811428 · Universal Prosthetics, Inc. · Ear, Nose, Throat device
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Jun 1981
Decision
25d
Days
Class 1
Risk

K811428 is an FDA 510(k) clearance for the NORTHWESTERN VOICE RESTORATION KIT. Classified as Tube, Laryngectomy (product code KAC), Class I - General Controls.

Submitted by Universal Prosthetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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: 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 Universal Prosthetics, Inc. devices

Submission Details

510(k) Number K811428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 16, 1981
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAC Tube, Laryngectomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.