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Paragonix Technologies, Inc.: FDA-registered device maker in Waltham, MA, United States, 5 510(k) clearances

Name: Paragonix Technologies, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Paragonix Technologies, Inc. is registered with the FDA (registration 3011175555) in Waltham, MA, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 23, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011175555
Address: 950 Winter Street, North, Waltham, MA, United States, 02451
Owner or operator: Paragonix Technologies (10057453)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: April 6, 2018
Registered through: 2026
Brand names listed: BAROguard, KidneyVault, PancreasPak Organ Preservation System, SherpaPak Cardiac Transport System, SherpaPak Kidney Transport System, SherpaPak LIVERguard, SherpaPak LUNGguard

Devices it lists

Device	Product code	Class	Role	Source
System And Accessories, Isolated Heart, Transport And Preservation	MSB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Perfusion, Kidney	KDN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 23, 2024	K234060	KIDNEYvault Portable Renal Perfusion System	KDN	Substantially Equivalent	Paragonix Technologies	accessdata.fda.gov
August 15, 2023	K223874	BAROguard	KDN	Substantially Equivalent	Paragonix Technologies	accessdata.fda.gov
January 16, 2020	K192869	SherpaPak Lung Preservation System , SherpaPak Liver Transport System	KDN	Unknown	Pragonix Technologies	accessdata.fda.gov
December 20, 2019	K191440	Paragonix SherpaPak Pancreas Transport System	KDN	Substantially Equivalent	Paragonix Technologies	accessdata.fda.gov
March 30, 2018	K180194	SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System	MSB	Substantially Equivalent	Paragonix Technologies, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 20, 2026	99476	Class II	Ongoing	Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001	Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.	accessdata.fda.gov

Compare with other makers

Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.