Cleared Traditional

VOCALTECH VOCAL FEEDBACK DEVICE (K871590) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K871590 · Vocaltech C/O Hogan & Hartson · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
165d
Days
Class 1
Risk

K871590 is an FDA 510(k) clearance for the VOCALTECH VOCAL FEEDBACK DEVICE. Classified as Device, Anti-stammering (product code KTH), Class I - General Controls.

Submitted by Vocaltech C/O Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on October 6, 1987 after a review of 165 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5840 - 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 Vocaltech C/O Hogan & Hartson devices

Submission Details

510(k) Number K871590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1987
Decision Date October 06, 1987
Days to Decision 165 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
76d slower than avg
Panel avg: 89d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTH Device, Anti-stammering
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5840
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.