Cleared Traditional

K894968 - ULTRACOMPACT

K894968 is an FDA 510(k) clearance for ULTRACOMPACT, manufactured by Eutectic Electronics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EXY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K894968 · Eutectic Electronics, Inc. · Gastroenterology & Urology device
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Nov 1989
Decision
93d
Days
Class 2
Risk

K894968 is an FDA 510(k) clearance for the ULTRACOMPACT. Classified as Uroflowmeter (product code EXY), Class II - Special Controls.

Submitted by Eutectic Electronics, Inc. (Raleigh, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 93 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 Eutectic Electronics, Inc. devices

FDA 510(k) Submission Details - K894968

510(k) Number K894968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1989
Decision Date November 08, 1989
Days to Decision 93 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
38d faster than avg
Panel avg: 131d · This submission: 93d
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 8
Devices cleared under the same product code (EXY) and FDA review panel - the closest regulatory comparables to K894968.
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