Cleared Traditional

K822163 - ENT RETRACTORS

K822163 is the FDA 510(k) clearance for ENT RETRACTORS by Kelleher Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K822163 · Kelleher Corp. · Ear, Nose, Throat device
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Aug 1982
Decision
19d
Days
Class 1
Risk

K822163 is an FDA 510(k) clearance for the ENT RETRACTORS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on August 11, 1982 after a review of 19 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 Kelleher Corp. devices

Submission Details

510(k) Number K822163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1982
Decision Date August 11, 1982
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
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 660
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K822163.
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K821987 · Oticon Corp. · Aug 1982
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K821899 · Unitron Industries, Inc. · Jul 1982
HEARING AID, UNITRON MODEL UE5
K821900 · Unitron Industries, Inc. · Jul 1982
SERIES M PUSH-PULL INPUT COMPRESSION
K821760 · Maico Hearing Instruments, Inc. · Jun 1982