Cleared Traditional

K891585 - HYDRO-SAN COLONIC IRRIGATION SYSTEM

K891585 is an FDA 510(k) clearance for HYDRO-SAN COLONIC IRRIGATION SYSTEM, manufactured by Specialty Health Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K891585 · Specialty Health Products, Inc. · Gastroenterology & Urology device
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Aug 1989
Decision
136d
Days
Class 2
Risk

K891585 is an FDA 510(k) clearance for the HYDRO-SAN COLONIC IRRIGATION SYSTEM. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Specialty Health Products, Inc. (Phoenix, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 136 days - within the typical 510(k) review window.

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.

View all Specialty Health Products, Inc. devices

FDA 510(k) Submission Details - K891585

510(k) Number K891585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date August 03, 1989
Days to Decision 136 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
5d slower than avg
Panel avg: 131d · This submission: 136d
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.

Regulatory Peers - KPL Colonic Irrigation System

All 22
Devices cleared under the same product code (KPL) and FDA review panel - the closest regulatory comparables to K891585.
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
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CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
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CUFF SPECULUM
K893531 · Mountain Medical Equipment, Inc. · Jun 1989
SARNS INFANT ARTERIAL BUBBLE SENSOR
K803105 · 3M Health Care, Sarns · Dec 1980