Cleared Traditional

K893431 - AUDITORY TRAINER PE150R FM RECEIVER

K893431 is an FDA 510(k) clearance for AUDITORY TRAINER PE150R FM RECEIVER, manufactured by Phonic Ear, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EPF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K893431 · Phonic Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
111d
Days
Class 2
Risk

K893431 is an FDA 510(k) clearance for the AUDITORY TRAINER PE150R FM RECEIVER. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Phonic Ear, Inc. (Mill Valley, US). The FDA issued a Cleared decision on August 21, 1989 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 874.3320 - 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: 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 Phonic Ear, Inc. devices

FDA 510(k) Submission Details - K893431

510(k) Number K893431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date August 21, 1989
Days to Decision 111 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
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. No clinical trials required.

EPF Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K893431.
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
K913494 · Telex Communications, Inc. · Nov 1991
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
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
K882409 · Phonic Ear, Inc. · Jul 1988
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
K881099 · Phonic Ear, Inc. · Jun 1988
PHONIC EAR, MODEL PE475R
K862773 · Phonic Ear, Inc. · Oct 1986