Cleared Traditional

K833043 - UROMETER

K833043 is the FDA 510(k) clearance for UROMETER by Browne Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFG) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K833043 · Browne Medical, Inc. · Gastroenterology & Urology device
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Feb 1984
Decision
151d
Days
Class 2
Risk

K833043 is an FDA 510(k) clearance for the UROMETER. Classified as Device, Urine Flow Rate Measuring, Non-electrical, Disposable (product code FFG), Class II - Special Controls.

Submitted by Browne Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 151 days - an extended review cycle.

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 Browne Medical, Inc. devices

Submission Details

510(k) Number K833043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date February 04, 1984
Days to Decision 151 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
21d slower than avg
Panel avg: 130d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (FFG) and FDA review panel - the closest regulatory comparables to K833043.
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