Cleared Traditional

K781923 - NON-RETENTION ENEMA SYSTEM

K781923 is an FDA 510(k) clearance for NON-RETENTION ENEMA SYSTEM, manufactured by Hudson Kendale Assoc., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K781923 · Hudson Kendale Assoc., Inc. · Gastroenterology & Urology device
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Aug 1979
Decision
260d
Days
Class 2
Risk

K781923 is an FDA 510(k) clearance for the NON-RETENTION ENEMA SYSTEM. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Hudson Kendale Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 260 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5220 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K781923

510(k) Number K781923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1978
Decision Date August 03, 1979
Days to Decision 260 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 131d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPL Device Classification - Class 2, Special Controls

Product Code KPL Colonic Irrigation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.