Cleared Traditional

PERFADEX SOLUTION FOR ORGAN PRESERVATION (K000881) - FDA 510(k) Clearance

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

K000881 · Vitrolife Sweden AB · Gastroenterology & Urology device
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Mar 2001
Decision
353d
Days
Class 2
Risk

K000881 is an FDA 510(k) clearance for the PERFADEX SOLUTION FOR ORGAN PRESERVATION. Classified as System And Accessories, Isolated Heart, Transport And Preservation (product code MSB), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Ringoes, US). The FDA issued a Cleared decision on March 8, 2001 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K000881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date March 08, 2001
Days to Decision 353 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
223d slower than avg
Panel avg: 130d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSB System And Accessories, Isolated Heart, Transport And Preservation
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 - MSB System And Accessories, Isolated Heart, Transport And Preservation

All 12
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