Data / Medical devices / United States / Waters Medical Systems, LLC

Waters Medical Systems, LLC: FDA-registered device maker in Rochester, MN, United States, 11 510(k) clearances

Name: Waters Medical Systems, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Waters Medical Systems, LLC is registered with the FDA (registration 2123774) in Rochester, MN, United States. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 14, 2022. 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: 2123774
Address: 2900 37th St NW Building 003, Rochester, MN, United States, 55901
Owner or operator: Waters Medical Systems LLC (10024390)
Roles: Complaint file establishment, Manufacturer
First device listed: July 31, 2008
Registered through: 2026
Brand names listed: BEL-GEN Cold Storage Solution, CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS, CSS, CoStorSol, Oxicom 2100, Oxicom 3000, Oxicom Liquid Control, PERF-GEN Pulsatile Perfusion Solution and more

Devices it lists

Device	Product code	Class	Role	Source
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Set, Perfusion, Kidney, Disposable	KDL	2	Complaint file establishment	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment	accessdata.fda.gov
System And Accessories, Isolated Heart, Transport And Preservation	MSB	2	Complaint file establishment	accessdata.fda.gov
System, Perfusion, Kidney	KDN	2	Complaint file establishment, Manufacturer	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
June 14, 2022	K221387	BEL-GEN Cold Storage Solution	KDL	Substantially Equivalent	Institut Georges Lopez	accessdata.fda.gov
June 14, 2022	K221386	PERF-GEN Pulsatile Perfusion Solution	KDL	Substantially Equivalent	Institut Georges Lopez	accessdata.fda.gov
October 15, 2021	K211224	RM4 Control Unit	KDN	Substantially Equivalent	Institut Georges Lopez	accessdata.fda.gov
February 16, 2012	K111521	WAVES	KDN	Substantially Equivalent	Waters Medical Systems, LLC	accessdata.fda.gov
August 8, 2008	K080432	MAPERSOL	KDN	Substantially Equivalent	Preservation Solutions, Inc.	accessdata.fda.gov
July 3, 2008	K073693	COSTORSOL	KDN	Substantially Equivalent	Preservation Solutions, Inc.	accessdata.fda.gov
January 26, 2006	K053327	OXICOM CONTROL	JJX	Substantially Equivalent	Bionostics, Inc.	accessdata.fda.gov
August 5, 1999	K991594	CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS	MSB	Substantially Equivalent	Sangstat Medical Corp.	accessdata.fda.gov
July 29, 1997	K971571	RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT	KDN	Substantially Equivalent	Waters Instruments, Inc.	accessdata.fda.gov
October 23, 1992	K921519	OXICOM-2100	DQA	Substantially Equivalent	Waters Instruments, Inc.	accessdata.fda.gov
August 26, 1991	K911207	OXICOMPLUS	DQA	Substantially Equivalent	Waters Instruments, 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
March 21, 2022	89841	Class II	Terminated	WAVES WCM Kidney Cassette Module	There is a potential for the WCM cassette pump head leaking solution.	accessdata.fda.gov

Compare with other makers

Updated June 14, 2022. 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.