Cleared Traditional

K821447 - MODEL BERUAFON T85 & T95

K821447 is an FDA 510(k) clearance for MODEL BERUAFON T85 & T95, manufactured by Beruafon, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K821447 · Beruafon, Inc. · Ear, Nose, Throat device
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Jun 1982
Decision
26d
Days
Class 1
Risk

K821447 is an FDA 510(k) clearance for the MODEL BERUAFON T85 & T95. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Beruafon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1982 after a review of 26 days - a notably fast clearance cycle.

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: 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 Beruafon, Inc. devices

FDA 510(k) Submission Details - K821447

510(k) Number K821447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1982
Decision Date June 09, 1982
Days to Decision 26 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
63d faster than avg
Panel avg: 89d · This submission: 26d
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 K821447.
HEARING AID, UNITRON MODEL UE5
K821900 · Unitron Industries, Inc. · Jul 1982
SERIES M PUSH-PULL INPUT COMPRESSION
K821760 · Maico Hearing Instruments, Inc. · Jun 1982
MODEL AH BEHING-THE-EAR-HEARING AID
K821550 · Dahlberg Electronics, Inc. · Jun 1982
OTICON
K821325 · Oticon Corp. · Jun 1982
MODEL 28C HEAPING AID
K821132 · Telex Communications, Inc. · May 1982
RIONET HEARING AID HA-57
K820656 · Rion Acoustic Instruments, Inc. · Apr 1982