Cleared Traditional

K925237 - AUTOMATIC CALORIC IRRIGATION SYSTEM

K925237 is an FDA 510(k) clearance for AUTOMATIC CALORIC IRRIGATION SYSTEM, manufactured by Ics Medical Corp.. The device is a Class 1 Ear, Nose, Throat device with product code KHH cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K925237 · Ics Medical Corp. · Ear, Nose, Throat device
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May 1993
Decision
201d
Days
Class 1
Risk

K925237 is an FDA 510(k) clearance for the AUTOMATIC CALORIC IRRIGATION SYSTEM. Classified as Stimulator, Caloric-air (product code KHH), Class I - General Controls.

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 201 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 Ics Medical Corp. devices

FDA 510(k) Submission Details - K925237

510(k) Number K925237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date May 05, 1993
Days to Decision 201 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
111d slower than avg
Panel avg: 90d · This submission: 201d
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.