Cleared Traditional

K192869 - SherpaPak Lung Preservation System

K192869 is an FDA 510(k) clearance for SherpaPak Lung Preservation System, manufactured by Pragonix Technologies. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K192869 · Pragonix Technologies · Gastroenterology & Urology device
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Jan 2020
Decision
101d
Days
Class 2
Risk

K192869 is an FDA 510(k) clearance for the SherpaPak Lung Preservation System , SherpaPak Liver Transport System. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Pragonix Technologies (Braintree, US). The FDA issued a Cleared decision on January 16, 2020 after a review of 101 days - within the typical 510(k) review window.

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 Pragonix Technologies devices

FDA 510(k) Submission Details - K192869

510(k) Number K192869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 07, 2019
Decision Date January 16, 2020
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
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 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 21
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K180481 · S.A.L.F. Spa · Jun 2018