Cleared Traditional

K913494 - TELEX TDR-4AA MONAURAL HEAR AID/WIRELES...

K913494 is the FDA 510(k) clearance for TELEX TDR-4AA MONAURAL HEAR AID/WIRELES... by Telex Communications, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EPF) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K913494 · Telex Communications, Inc. · Ear, Nose, Throat device
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Nov 1991
Decision
87d
Days
Class 2
Risk

K913494 is an FDA 510(k) clearance for the TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 1, 1991 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Telex Communications, Inc. devices

Submission Details

510(k) Number K913494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date November 01, 1991
Days to Decision 87 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
2d faster than avg
Panel avg: 89d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EPF Hearing Aid, Group And Auditory Trainer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EPF Hearing Aid, Group And Auditory Trainer

All 20
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K913494.
TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915384 · Telex Communications, Inc. · Jan 1992
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER
K915397 · Telex Communications, Inc. · Jan 1992
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER
K915398 · Telex Communications, Inc. · Jan 1992
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC
K913495 · Telex Communications, Inc. · Nov 1991
GROUP AUDITORY TRAINER,FM RECEIVER
K912356 · Phonic Ear, Inc. · Aug 1991
AUDITORY TRAINER PE150R FM RECEIVER
K893431 · Phonic Ear, Inc. · Aug 1989