Cleared Traditional

K950785 - HORTMANN AIRMATIC AIR CALORIC STIMULATOR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K950785 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Jun 1995
Decision
127d
Days
Class 1
Risk

K950785 is an FDA 510(k) clearance for the HORTMANN AIRMATIC AIR CALORIC STIMULATOR. Classified as Stimulator, Caloric-air (product code KHH), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on June 28, 1995 after a review of 127 days - within the typical 510(k) review window.

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 K950785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date June 28, 1995
Days to Decision 127 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 89d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHH Stimulator, Caloric-air
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.