Cleared Traditional

AUTOMATIC CALORIC IRRIGATION SYSTEM (K881630) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K881630 · Ics Medical Corp. · Ear, Nose, Throat device
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Jun 1988
Decision
68d
Days
Class 1
Risk

K881630 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 June 21, 1988 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ics Medical Corp. devices

Submission Details

510(k) Number K881630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1988
Decision Date June 21, 1988
Days to Decision 68 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 89d · This submission: 68d
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.