Cleared Traditional

WATER IRRIGATOR, W1 200 (K941325) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K941325 · Strong Medical, Inc. · Ear, Nose, Throat device
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Aug 1994
Decision
144d
Days
Class 1
Risk

K941325 is an FDA 510(k) clearance for the WATER IRRIGATOR, W1 200. Classified as Stimulator, Caloric-air (product code KHH), Class I - General Controls.

Submitted by Strong Medical, Inc. (Heraklion, GR). The FDA issued a Cleared decision on August 9, 1994 after a review of 144 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 Strong Medical, Inc. devices

Submission Details

510(k) Number K941325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date August 09, 1994
Days to Decision 144 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
55d slower than avg
Panel avg: 89d · This submission: 144d
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.