Cleared Special

K143054 - Sherpa Pak Kidney Transport System (FDA 510(k) Clearance)

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

K143054 · Paragonix Technologies, Inc. · Gastroenterology & Urology device
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Nov 2014
Decision
33d
Days
Class 2
Risk

K143054 is an FDA 510(k) clearance for the Sherpa Pak Kidney Transport System. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Paragonix Technologies, Inc. (Braintree, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 33 days - a notably fast clearance cycle.

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: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Paragonix Technologies, Inc. devices

Submission Details

510(k) Number K143054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 23, 2014
Decision Date November 25, 2014
Days to Decision 33 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
97d faster than avg
Panel avg: 130d · This submission: 33d
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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