Cleared Traditional

K091656 - SPS-1TM STATIC PRESERVATION SOLUTION

K091656 is an FDA 510(k) clearance for SPS-1TM STATIC PRESERVATION SOLUTION, manufactured by Organ Recovery Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDL cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K091656 · Organ Recovery Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
275d
Days
Class 2
Risk

K091656 is an FDA 510(k) clearance for the SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L. Classified as Set, Perfusion, Kidney, Disposable (product code KDL), Class II - Special Controls.

Submitted by Organ Recovery Systems, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 11, 2010 after a review of 275 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 Organ Recovery Systems, Inc. devices

FDA 510(k) Submission Details - K091656

510(k) Number K091656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date March 11, 2010
Days to Decision 275 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
145d slower than avg
Panel avg: 130d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDL Device Classification - Class 2, Special Controls

Product Code KDL Set, Perfusion, Kidney, Disposable
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 - KDL Set, Perfusion, Kidney, Disposable

All 9
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