Cleared Special

K091989 - PERFADEX AND PERFADEX WITH THAM

K091989 is an FDA 510(k) clearance for PERFADEX AND PERFADEX WITH THAM, manufactured by Xvivo Perfusion AB. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Special 510(k) pathway after a 456-day FDA review.

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

FDA 510(k) Submission Details - K091989

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 131d · This submission: 456d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - KDN System, Perfusion, Kidney

All 40
Devices cleared under the same product code (KDN) and FDA review panel - the closest regulatory comparables to K091989.
Sherpa Pak Kidney Transport System
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SHERPA PAK TRANSPORTER
K133694 · Paragonix Technologies, Inc. · May 2014
WAVES
K111521 · Waters Medical Systems, LLC · Feb 2012
COSTORSOL
K091245 · Preservation Solutions, Inc. · Jun 2009
COSTORSOL
K083453 · Preservation Solutions, Inc. · Jan 2009
MAPERSOL
K080432 · Preservation Solutions, Inc. · Aug 2008