Cleared Traditional

K971913 - GR100F URINE FLOWMETER

K971913 is an FDA 510(k) clearance for GR100F URINE FLOWMETER, manufactured by Albyn Medical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EXY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K971913 · Albyn Medical , Ltd. · Gastroenterology & Urology device
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Sep 1997
Decision
120d
Days
Class 2
Risk

K971913 is an FDA 510(k) clearance for the GR100F URINE FLOWMETER. Classified as Uroflowmeter (product code EXY), Class II - Special Controls.

Submitted by Albyn Medical , Ltd. (Dingwall, Ross-Shire, GB). The FDA issued a Cleared decision on September 19, 1997 after a review of 120 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 Albyn Medical , Ltd. devices

FDA 510(k) Submission Details - K971913

510(k) Number K971913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1997
Decision Date September 19, 1997
Days to Decision 120 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 131d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXY Device Classification - Class 2, Special Controls

Product Code EXY Uroflowmeter
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 - EXY Uroflowmeter

All 7
Devices cleared under the same product code (EXY) and FDA review panel - the closest regulatory comparables to K971913.
Uroflowmeter
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