Cleared Traditional

K833882 - INSTRUMENT CABINET

K833882 is the FDA 510(k) clearance for INSTRUMENT CABINET by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code ETF) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K833882 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Jan 1984
Decision
79d
Days
Class 1
Risk

K833882 is an FDA 510(k) clearance for the INSTRUMENT CABINET. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 79 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K833882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1983
Decision Date January 27, 1984
Days to Decision 79 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
10d faster than avg
Panel avg: 89d · This submission: 79d
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 23
Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K833882.
JEDMED MAXIM ENT CABINET
K881958 · Jedmed Instrument Co. · Jul 1988
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K860940 · Micromedics, Inc. · May 1986
LARYNGEAL MIRROR PRE-WARMER
K855021 · Jedmed Instrument Co. · Mar 1986
ENT TREATMENT UNITS
K822252 · Kelleher Corp. · Nov 1982
MULTIPLE, ENT CABINET #448
K822531 · Midmark Corp. · Sep 1982
NAGASHIMA SN-SP UNIT AND CHAIR
K822016 · Kelleher Corp. · Sep 1982