Cleared Traditional

K822252 - ENT TREATMENT UNITS

K822252 is an FDA 510(k) clearance for ENT TREATMENT UNITS, manufactured by Kelleher Corp.. The device is a Class 1 Ear, Nose, Throat device with 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

FDA 510(k) Submission Details - K822252

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
26d slower than avg
Panel avg: 90d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

ETF Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K822252.
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K860940 · Micromedics, Inc. · May 1986
LARYNGEAL MIRROR PRE-WARMER
K855021 · Jedmed Instrument Co. · Mar 1986
INSTRUMENT CABINET
K833882 · Jedmed Instrument Co. · Jan 1984
MULTIPLE, ENT CABINET #448
K822531 · Midmark Corp. · Sep 1982
NAGASHIMA SN-SP UNIT AND CHAIR
K822016 · Kelleher Corp. · Sep 1982
MULTIPLE, ENT CHAIR #418
K822530 · Midmark Corp. · Sep 1982