Cleared Traditional

K940164 - SUPER-SIL

K940164 is an FDA 510(k) clearance for SUPER-SIL, manufactured by Finetone Hearing Instruments. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K940164 · Finetone Hearing Instruments · Ear, Nose, Throat device
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Jun 1994
Decision
174d
Days
Class 1
Risk

K940164 is an FDA 510(k) clearance for the SUPER-SIL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Finetone Hearing Instruments (South Portland, US). The FDA issued a Cleared decision on June 29, 1994 after a review of 174 days - an extended review cycle.

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 Finetone Hearing Instruments devices

FDA 510(k) Submission Details - K940164

510(k) Number K940164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1994
Decision Date June 29, 1994
Days to Decision 174 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 89d · This submission: 174d
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 K940164.
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
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K942213 · Beltone Electronics Corp. · Jun 1994