Cleared Traditional

K854001 - CERTI-FORM

K854001 is an FDA 510(k) clearance for CERTI-FORM, manufactured by Beltone Electronics Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K854001 · Beltone Electronics Corp. · Ear, Nose, Throat device
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Dec 1985
Decision
92d
Days
Class 1
Risk

K854001 is an FDA 510(k) clearance for the CERTI-FORM. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Beltone Electronics Corp. (Chicago, US). The FDA issued a Cleared decision on December 31, 1985 after a review of 92 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 Beltone Electronics Corp. devices

FDA 510(k) Submission Details - K854001

510(k) Number K854001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date December 31, 1985
Days to Decision 92 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
2d slower than avg
Panel avg: 90d · This submission: 92d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K854001.
DAHLBERG MODEL KC IN-THE-EAR HEARING AID
K854834 · Miracle-Ear/Dahlberg, Inc. · Mar 1986
THE ANSWER HEARING AID
K854438 · Electone, Inc. · Feb 1986
OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE
K854742 · Oticon Corp. · Feb 1986
INT'L MODEL XG BEHIND-THE-EAR HEARING AID
K853941 · Int'L Hearing Aids, Inc. · Dec 1985
INT'L MODEL XE BEHIND-THE-EAR HEARING AID
K853942 · Int'L Hearing Aids, Inc. · Dec 1985
WIDEX MODEL M1
K853793 · Widex Hearing Aid Co., Inc. · Dec 1985