Cleared Traditional

K941325 - WATER IRRIGATOR

K941325 is an FDA 510(k) clearance for WATER IRRIGATOR, manufactured by Strong Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KHH cleared through the Traditional 510(k) pathway after a 144-day FDA review.

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

FDA 510(k) Submission Details - K941325

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.

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.