Cleared Traditional

K133694 - SHERPA PAK TRANSPORTER

K133694 is an FDA 510(k) clearance for SHERPA PAK TRANSPORTER, manufactured by Paragonix Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K133694 · Paragonix Technologies, Inc. · Gastroenterology & Urology device
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May 2014
Decision
171d
Days
Class 2
Risk

K133694 is an FDA 510(k) clearance for the SHERPA PAK TRANSPORTER. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Paragonix Technologies, Inc. (Providence, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 171 days - an extended review cycle.

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. Standard predicate reliance. 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 Paragonix Technologies, Inc. devices

FDA 510(k) Submission Details - K133694

510(k) Number K133694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2013
Decision Date May 23, 2014
Days to Decision 171 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
40d slower than avg
Panel avg: 131d · This submission: 171d
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.

Regulatory Peers - KDN System, Perfusion, Kidney

All 39
Devices cleared under the same product code (KDN) and FDA review panel - the closest regulatory comparables to K133694.
Low Potassium Dextran Solution with Tris Diluent
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CoStorSol plus G
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WAVES
K111521 · Waters Medical Systems, LLC · Feb 2012
PERFADEX AND PERFADEX WITH THAM
K091989 · Xvivo Perfusion AB · Oct 2010
COSTORSOL
K091245 · Preservation Solutions, Inc. · Jun 2009