Cleared Traditional

K180194 - SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (FDA 510(k) Clearance)

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

K180194 · Paragonix Technologies, Inc. · Gastroenterology & Urology device
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Mar 2018
Decision
65d
Days
Class 2
Risk

K180194 is an FDA 510(k) clearance for the SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System. Classified as System And Accessories, Isolated Heart, Transport And Preservation (product code MSB), Class II - Special Controls.

Submitted by Paragonix Technologies, Inc. (Braintree, US). The FDA issued a Cleared decision on March 30, 2018 after a review of 65 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, Inc. devices

Submission Details

510(k) Number K180194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date March 30, 2018
Days to Decision 65 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 130d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.