Cleared Traditional

K822252 - ENT TREATMENT UNITS

K822252 is the FDA 510(k) clearance for ENT TREATMENT UNITS by Kelleher Corp.. It is a Class 1 Ear, Nose, Throat device (product code ETF) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K822252 · Kelleher Corp. · Ear, Nose, Throat device
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Nov 1982
Decision
116d
Days
Class 1
Risk

K822252 is an FDA 510(k) clearance for the ENT TREATMENT UNITS. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - 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 Kelleher Corp. devices

Submission Details

510(k) Number K822252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date November 22, 1982
Days to Decision 116 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
27d slower than avg
Panel avg: 89d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
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 - ETF Unit, Examining/treatment, Ent

All 19
Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K822252.
JEDMED MAXIM ENT CABINET
K881958 · Jedmed Instrument Co. · Jul 1988
LARYNGEAL MIRROR PRE-WARMER
K855021 · Jedmed Instrument Co. · Mar 1986
INSTRUMENT CABINET
K833882 · Jedmed Instrument Co. · Jan 1984
NAGASHIMA SN-SP UNIT AND CHAIR
K822016 · Kelleher Corp. · Sep 1982
ATMOSET
K810148 · Jedmed Instrument Co. · Feb 1981
ENTERMED ENTUNIT
K802712 · Jedmed Instrument Co. · Nov 1980