Cleared Traditional

SherpaPak Pediatric Liver Transport System (K201048) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201048 · Paragonix Technologies · Gastroenterology & Urology device
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Jul 2020
Decision
72d
Days
Class 2
Risk

K201048 is an FDA 510(k) clearance for the SherpaPak Pediatric Liver Transport System. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Paragonix Technologies (Braintree, US). The FDA issued a Cleared decision on July 2, 2020 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Paragonix Technologies devices

Submission Details

510(k) Number K201048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date July 02, 2020
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Northstar Biomedical Associates
Leo Basta

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KDN System, Perfusion, Kidney

All 20
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