Cleared Traditional

K820775 - VESTIBULARISET (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K820775 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Nov 1982
Decision
225d
Days
Class 1
Risk

K820775 is an FDA 510(k) clearance for the VESTIBULARISET. Classified as Stimulator, Caloric-water (product code ETP), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Walker, US). The FDA issued a Cleared decision on November 3, 1982 after a review of 225 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1800 - 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K820775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date November 03, 1982
Days to Decision 225 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 89d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETP Stimulator, Caloric-water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1800
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.