Cleared Traditional

K821991 - DANAVOS CUSTOM EAR

K821991 is an FDA 510(k) clearance for DANAVOS CUSTOM EAR, manufactured by Deravox, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K821991 · Deravox, Inc. · Ear, Nose, Throat device
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Aug 1982
Decision
36d
Days
Class 1
Risk

K821991 is an FDA 510(k) clearance for the DANAVOS CUSTOM EAR. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Deravox, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1982 after a review of 36 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 Deravox, Inc. devices

FDA 510(k) Submission Details - K821991

510(k) Number K821991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1982
Decision Date August 12, 1982
Days to Decision 36 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
53d faster than avg
Panel avg: 89d · This submission: 36d
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 K821991.
PHONIC EAR-PE 845-PPC
K822779 · Phonic Ear, Inc. · Oct 1982
HEARING AID, UNITRON UE3-D/DN
K822506 · Unitron Industries, Inc. · Sep 1982
EARETTE HEARING AID OPTICON MODEL E28P
K821987 · Oticon Corp. · Aug 1982
ENT RETRACTORS
K822163 · Kelleher Corp. · Aug 1982
HEARING AID, UNITRON MODELS UE3/3-N
K821899 · Unitron Industries, Inc. · Jul 1982
HEARING AID, UNITRON MODEL UE5
K821900 · Unitron Industries, Inc. · Jul 1982