Cleared Traditional

K933546 - V-SIL

K933546 is an FDA 510(k) clearance for V-SIL, manufactured by Esschem, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K933546 · Esschem, Inc. · Ear, Nose, Throat device
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Nov 1993
Decision
103d
Days
Class 1
Risk

K933546 is an FDA 510(k) clearance for the V-SIL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Esschem, Inc. (Essington, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 103 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 Esschem, Inc. devices

FDA 510(k) Submission Details - K933546

510(k) Number K933546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date November 02, 1993
Days to Decision 103 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
14d slower than avg
Panel avg: 89d · This submission: 103d
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 K933546.
CLARIFIER II CIRCUIT OPTION
K934597 · Miracle-Ear, Inc. · Nov 1993
OTOSONIC ADVANCED FULL SHIELD (AFS)
K934618 · Beltone Electronics Corp. · Nov 1993
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K931372 · Resound Corp. · Nov 1993
STARKEY TYMPANETTE HEARING AID
K933407 · Starkey Laboratories, Inc. · Oct 1993
BOSCH EUROSTAR
K933988 · Starkey Laboratories, Inc. · Oct 1993
RESOLUTION ITC HEARING AID
K933989 · Starkey Laboratories, Inc. · Oct 1993