Cleared Traditional

K023011 - OSMONICS SOLUTION DELIVERY SYSTEM

K023011 is an FDA 510(k) clearance for OSMONICS SOLUTION DELIVERY SYSTEM, manufactured by Osmonics Medical Systems. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K023011 · Osmonics Medical Systems · Gastroenterology & Urology device
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Jun 2003
Decision
290d
Days
Class 2
Risk

K023011 is an FDA 510(k) clearance for the OSMONICS SOLUTION DELIVERY SYSTEM. Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by Osmonics Medical Systems (Kent, US). The FDA issued a Cleared decision on June 26, 2003 after a review of 290 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Osmonics Medical Systems devices

FDA 510(k) Submission Details - K023011

510(k) Number K023011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date June 26, 2003
Days to Decision 290 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
160d slower than avg
Panel avg: 130d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIN Device Classification - Class 2, Special Controls

Product Code FIN Tank, Holding, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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.