Cleared Traditional

K971571 - RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (FDA 510(k) Clearance)

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

K971571 · Waters Instruments, Inc. · Gastroenterology & Urology device
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Jul 1997
Decision
90d
Days
Class 2
Risk

K971571 is an FDA 510(k) clearance for the RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Waters Instruments, Inc. (Rochester, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - 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 Waters Instruments, Inc. devices

Submission Details

510(k) Number K971571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1997
Decision Date July 29, 1997
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDN System, Perfusion, Kidney
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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 - KDN System, Perfusion, Kidney

All 41
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