Cleared Traditional

K000881 - PERFADEX SOLUTION FOR ORGAN PRESERVATION

K000881 is an FDA 510(k) clearance for PERFADEX SOLUTION FOR ORGAN PRESERVATION, manufactured by Vitrolife Sweden AB. The device is a Class 2 Gastroenterology & Urology device with product code MSB cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K000881 · Vitrolife Sweden AB · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K000881

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 131d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSB Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (MSB) and FDA review panel - the closest regulatory comparables to K000881.
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K133432 · Paragonix Technologies, Inc. · Feb 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K123326 · Paragonix Technologies, Inc. · Feb 2013
PERFADEX WITH THAM
K081997 · Vitrolife Sweden AB · Oct 2008
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
K991594 · Sangstat Medical Corp. · Aug 1999