Cleared Traditional

K904756 - MATRICS

K904756 is the FDA 510(k) clearance for MATRICS by Kerr Corporation (Danbury). It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K904756 · Kerr Corporation (Danbury) · Ear, Nose, Throat device
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Mar 1991
Decision
147d
Days
Class 1
Risk

K904756 is an FDA 510(k) clearance for the MATRICS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Kerr Corporation (Danbury) (Romulus, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 147 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 Kerr Corporation (Danbury) devices

Submission Details

510(k) Number K904756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date March 15, 1991
Days to Decision 147 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
58d slower than avg
Panel avg: 89d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
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 - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K904756.
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3M MODEL 8240 ITE HEARING AID
K910690 · 3M Company · Mar 1991
POST AURICULAR HEARING AID MODEL PICO SC-H
K910028 · Phonak, Inc. · Mar 1991
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
K910012 · Phonak, Inc. · Feb 1991