Cleared Traditional

K860170 - VOROBA TECHNOLOGIES

K860170 is an FDA 510(k) clearance for VOROBA TECHNOLOGIES, manufactured by Voroba Technologies Assoc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K860170 · Voroba Technologies Assoc. · Ear, Nose, Throat device
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Apr 1986
Decision
90d
Days
Class 1
Risk

K860170 is an FDA 510(k) clearance for the VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Voroba Technologies Assoc. (Minnetonka, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 - K860170

510(k) Number K860170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date April 17, 1986
Days to Decision 90 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
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
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.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K860170.
PHONIC EAR PE 602 PPCS
K862229 · Phonic Ear, Inc. · Jul 1986
BEHING-THE-EAR HEARING AID SERIES SP
K861597 · Maico Hearing Instruments, Inc. · Jun 1986
RIONET HEARING AID
K861728 · Rion Acoustic Instruments, Inc. · May 1986
DAHLBERG MODEL UT IN-THE-EAR HEARING AID
K860670 · Dahlberg Electronics, Inc. · Apr 1986
MODEL 353C HEARING AID
K860035 · Telex Communications, Inc. · Mar 1986
AM 12, HEARING AID
K860007 · Electone, Inc. · Mar 1986