Cleared Traditional

K944896 - MATRICS IMPRESSION MATERIAL

K944896 is an FDA 510(k) clearance for MATRICS IMPRESSION MATERIAL, manufactured by Matrics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K944896 · Matrics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
143d
Days
Class 1
Risk

K944896 is an FDA 510(k) clearance for the MATRICS IMPRESSION MATERIAL , SYSTEM. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Matrics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 143 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 Matrics, Inc. devices

FDA 510(k) Submission Details - K944896

510(k) Number K944896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1994
Decision Date February 24, 1995
Days to Decision 143 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 89d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K944896.
MAICO IN-THE-EAR MODEL RD-312 CIC
K950637 · Maico Hearing Instruments, Inc. · Mar 1995
DYNA 231X
K950758 · Phonak, Inc. · Mar 1995
RESOUND(R) RESOURCE(TM)
K945750 · Resound Corp. · Mar 1995
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
K950319 · Resound Corp. · Feb 1995
LX-ITC
K946071 · Widex Hearing Aid Co., Inc. · Jan 1995
MAICO IN-THE-EAR MODEL RD 201
K946253 · Maico Hearing Instruments, Inc. · Jan 1995