Cleared Traditional

K860171 - VOROBA PROGRAMMABLE AUDITORY COMPARATOR

K860171 is an FDA 510(k) clearance for VOROBA PROGRAMMABLE AUDITORY COMPARATOR, manufactured by Voroba Technologies Assoc.. The device is a Class 2 Ear, Nose, Throat device with product code KHL cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K860171

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.

KHL Device Classification - Class 2, Special Controls

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.