510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201048Substantially Equivalent

SherpaPak Pediatric Liver Transport System

Paragonix Technologies Inc., Braintree MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K201048 is the FDA 510(k) clearance record for SherpaPak Pediatric Liver Transport System, a class II device, cleared for Paragonix Technologies on under FDA product code KDN (System, Perfusion, Kidney). FDA records list 12 510(k) clearances for Paragonix Technologies, from to . As of , FDA records show no recalls naming K201048.

Clearance record

Decision date
Received
(72 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Paragonix Technologies Suite 408, 639 Granite St., Braintree MA
510(k) summary
Statement
Third party review
No

Clearances, product code KDN

Trailing 12 months
3 clearances under product code KDN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260