Cleared Special

K091989 - PERFADEX AND PERFADEX WITH THAM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K091989 · Xvivo Perfusion AB · Gastroenterology & Urology device
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Oct 2010
Decision
456d
Days
Class 2
Risk

K091989 is an FDA 510(k) clearance for the PERFADEX AND PERFADEX WITH THAM. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Xvivo Perfusion AB (Gutengurg, SE). The FDA issued a Cleared decision on October 1, 2010 after a review of 456 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Xvivo Perfusion AB devices

Submission Details

510(k) Number K091989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2009
Decision Date October 01, 2010
Days to Decision 456 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
326d slower than avg
Panel avg: 130d · This submission: 456d
Pathway characteristics
Modification to existing cleared device.

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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