Cleared Traditional

VOROBA PROGRAMMABLE AUDITORY COMPARATOR (K860171) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860171 · Voroba Technologies Assoc. · Ear, Nose, Throat device
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May 1986
Decision
105d
Days
Class 2
Risk

K860171 is an FDA 510(k) clearance for the VOROBA PROGRAMMABLE AUDITORY COMPARATOR. Classified as Hearing Aid, Master (product code KHL), Class II - Special Controls.

Submitted by Voroba Technologies Assoc. (Minnetonka, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3330 - 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 Voroba Technologies Assoc. devices

Submission Details

510(k) Number K860171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date May 02, 1986
Days to Decision 105 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
16d slower than avg
Panel avg: 89d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHL Hearing Aid, Master
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.