Cleared Traditional

K832190 - METAVOX MV-1000 AUDITORY TRAINER

K832190 is an FDA 510(k) clearance for METAVOX MV-1000 AUDITORY TRAINER, manufactured by Metavox, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EPF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K832190 · Metavox, Inc. · Ear, Nose, Throat device
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Sep 1983
Decision
66d
Days
Class 2
Risk

K832190 is an FDA 510(k) clearance for the METAVOX MV-1000 AUDITORY TRAINER. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Metavox, Inc. (Walker, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 66 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 Metavox, Inc. devices

FDA 510(k) Submission Details - K832190

510(k) Number K832190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date September 12, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 89d · This submission: 66d
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 21
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K832190.
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
PHONIC EAR PE 467R-PE 461T
K832080 · Phonic Ear, Inc. · Aug 1983