Cleared Traditional

K935048 - ARTISAN PROGRAMMER & HEARING AID

K935048 is an FDA 510(k) clearance for ARTISAN PROGRAMMER & HEARING AID, manufactured by Telex Communications, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K935048 · Telex Communications, Inc. · Ear, Nose, Throat device
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Feb 1994
Decision
111d
Days
Class 1
Risk

K935048 is an FDA 510(k) clearance for the ARTISAN PROGRAMMER & HEARING AID. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 111 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 Telex Communications, Inc. devices

FDA 510(k) Submission Details - K935048

510(k) Number K935048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date February 09, 1994
Days to Decision 111 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
21d slower than avg
Panel avg: 90d · This submission: 111d
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 K935048.
FACEPLATE ASSEMBLY
K974219 · Finetone Hearing Instruments · Feb 1998
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
K961593 · Segi Hearing Aid Co. · Nov 1996
MODULE PROGRAM
K942722 · Electone, Inc. · Sep 1994
GOLD K AMP, ITE
K933037 · Electone, Inc. · Aug 1993
GOLD AF MODULE, ITE
K933038 · Electone, Inc. · Aug 1993
GOLD L MODULE, ITE
K933039 · Electone, Inc. · Aug 1993