Cleared Traditional

K820775 - VESTIBULARISET

K820775 is an FDA 510(k) clearance for VESTIBULARISET, manufactured by Jedmed Instrument Co.. The device is a Class 1 Ear, Nose, Throat device with product code ETP cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K820775

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 90d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

ETP Device Classification - Class 1, General Controls

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.