Cleared Traditional

K844338 - 1URO-LOG HOME DIAGNOSTIC PACK

K844338 is an FDA 510(k) clearance for 1URO-LOG HOME DIAGNOSTIC PACK, manufactured by Epcom Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFG cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K844338 · Epcom Medical Systems, Inc. · Gastroenterology & Urology device
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Feb 1985
Decision
109d
Days
Class 2
Risk

K844338 is an FDA 510(k) clearance for the 1URO-LOG HOME DIAGNOSTIC PACK. Classified as Device, Urine Flow Rate Measuring, Non-electrical, Disposable (product code FFG), Class II - Special Controls.

Submitted by Epcom Medical Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1800 - 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 Epcom Medical Systems, Inc. devices

FDA 510(k) Submission Details - K844338

510(k) Number K844338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1984
Decision Date February 25, 1985
Days to Decision 109 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
22d faster than avg
Panel avg: 131d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFG Device Classification - Class 2, Special Controls

Product Code FFG Device, Urine Flow Rate Measuring, Non-electrical, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1800
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 - FFG Device, Urine Flow Rate Measuring, Non-electrical, Disposable

All 7
Devices cleared under the same product code (FFG) and FDA review panel - the closest regulatory comparables to K844338.
SURGITEK (R) UROFLOW SYSTEM
K883274 · Medical Engineering Corp. · Feb 1989
ACCUMETER ELECTRONIC URINEMETER SYSTEM
K844030 · Travenol Laboratories, S.A. · Nov 1984
UROPUMP MODEL 1711
K843224 · Life-Tech Intl., Inc. · Oct 1984
UREOFIX 500 URINE MEASURING SYSTEM
K813082 · Burron Medical Products, Inc. · Dec 1981
UROFLOWMETER
K811925 · C.R. Bard, Inc. · Sep 1981
FLUID MEASUREMENT STAND
K790365 · Hewlett-Packard Co. · May 1979