Cleared Traditional

K021362 - LIFEPORT

K021362 is an FDA 510(k) clearance for LIFEPORT, manufactured by Organ Recovery Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 457-day FDA review.

K021362 · Organ Recovery Systems, Inc. · Gastroenterology & Urology device
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Jul 2003
Decision
457d
Days
Class 2
Risk

K021362 is an FDA 510(k) clearance for the LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR). Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Organ Recovery Systems, Inc. (Charleston, US). The FDA issued a Cleared decision on July 31, 2003 after a review of 457 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: 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 Organ Recovery Systems, Inc. devices

FDA 510(k) Submission Details - K021362

510(k) Number K021362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2002
Decision Date July 31, 2003
Days to Decision 457 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 130d · This submission: 457d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.