Cleared Traditional

K822016 - NAGASHIMA SN-SP UNIT AND CHAIR

K822016 is the FDA 510(k) clearance for NAGASHIMA SN-SP UNIT AND CHAIR by Kelleher Corp.. It is a Class 1 Ear, Nose, Throat device (product code ETF) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K822016 · Kelleher Corp. · Ear, Nose, Throat device
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Sep 1982
Decision
68d
Days
Class 1
Risk

K822016 is an FDA 510(k) clearance for the NAGASHIMA SN-SP UNIT AND CHAIR. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 68 days - a notably fast clearance cycle.

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: 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 K822016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1982
Decision Date September 14, 1982
Days to Decision 68 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
21d faster than avg
Panel avg: 89d · This submission: 68d
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 K822016.
LARYNGEAL MIRROR PRE-WARMER
K855021 · Jedmed Instrument Co. · Mar 1986
INSTRUMENT CABINET
K833882 · Jedmed Instrument Co. · Jan 1984
ENT TREATMENT UNITS
K822252 · Kelleher Corp. · Nov 1982
ATMOSET
K810148 · Jedmed Instrument Co. · Feb 1981
ENTERMED ENTUNIT
K802712 · Jedmed Instrument Co. · Nov 1980
NOBLE MEDEL ENT TREATMENT UNIT
K801738 · Jedmed Instrument Co. · Aug 1980