Cleared Traditional

K933045 - SILVER RECHARGEABLE MODULE, ITE

K933045 is an FDA 510(k) clearance for SILVER RECHARGEABLE MODULE, manufactured by Electone, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K933045 · Electone, Inc. · Ear, Nose, Throat device
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Aug 1993
Decision
96d
Days
Class 1
Risk

K933045 is an FDA 510(k) clearance for the SILVER RECHARGEABLE MODULE, ITE. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 96 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 Electone, Inc. devices

FDA 510(k) Submission Details - K933045

510(k) Number K933045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date August 02, 1993
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 90d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

LRB Device Classification - Class 1, General Controls

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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 - LRB Face Plate Hearing Aid

All 18
Devices cleared under the same product code (LRB) and FDA review panel - the closest regulatory comparables to K933045.
GOLD CD MODULE, ITE
K933040 · Electone, Inc. · Aug 1993
SILVER PPP MODULE, ITE
K933043 · Electone, Inc. · Aug 1993
SILVER LD MODULE, ITE
K933044 · Electone, Inc. · Aug 1993
SILVER L MODULE, ITE
K933046 · Electone, Inc. · Aug 1993
FACEPLATE ITE HEARING AID MODEL TCA
K910900 · Telex Communications, Inc. · May 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · Telex Communications, Inc. · May 1991