Cleared Traditional

AUTOMATIC CALORIC IRRIGATION SYSTEM (K925237) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

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

Submission Details

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
112d slower than avg
Panel avg: 89d · This submission: 201d
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.