Cleared Traditional

RIMECO MIDSTREAM URINE COLLECTOR (K943752) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943752 · Rimeco Products, Inc. · Gastroenterology & Urology device
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Nov 1994
Decision
91d
Days
Class 2
Risk

K943752 is an FDA 510(k) clearance for the RIMECO MIDSTREAM URINE COLLECTOR. Classified as Bag, Urine Collection, Newborn (product code FOC), Class II - Special Controls.

Submitted by Rimeco Products, Inc. (Oakwood Village, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Rimeco Products, Inc. devices

Submission Details

510(k) Number K943752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date November 01, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOC Bag, Urine Collection, Newborn
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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.