Cleared Traditional

K111521 - WAVES

K111521 is an FDA 510(k) clearance for WAVES, manufactured by Waters Medical Systems, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K111521 · Waters Medical Systems, LLC · Gastroenterology & Urology device
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Feb 2012
Decision
260d
Days
Class 2
Risk

K111521 is an FDA 510(k) clearance for the WAVES. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Waters Medical Systems, LLC (Rochester, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 260 days - an extended review cycle.

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 Medical Systems, LLC devices

FDA 510(k) Submission Details - K111521

510(k) Number K111521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2011
Decision Date February 16, 2012
Days to Decision 260 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
130d slower than avg
Panel avg: 130d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDN Device Classification - Class 2, Special Controls

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.