Cleared Traditional

K950785 - HORTMANN AIRMATIC AIR CALORIC STIMULATOR

K950785 is an FDA 510(k) clearance for HORTMANN AIRMATIC AIR CALORIC STIMULATOR, manufactured by Jedmed Instrument Co.. The device is a Class 1 Ear, Nose, Throat device with product code KHH cleared through the Traditional 510(k) pathway after a 127-day FDA review.

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

FDA 510(k) Submission Details - K950785

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 90d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

KHH Device Classification - Class 1, General Controls

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.