Data / Medical devices / United States / Preservation Solutions, Inc.

Preservation Solutions, Inc.: FDA-registered device maker in Elkhorn, WI, United States, 4 510(k) clearances

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

Preservation Solutions, Inc. is registered with the FDA (registration 2132588) in Elkhorn, WI, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 8, 2008. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2132588
FEI number: 1000221028
Address: 1099 Proctor Dr, Elkhorn, WI, United States, 53121
Owner or operator: PRESERVATION SOLUTIONS, INC. (9010760)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: December 4, 2007
Registered through: 2026
Brand names listed: Belzer UW Cold Storage Solution, ClearIt Anti-Fog Cloth, ClearIt Anti-Fog Kits, ClearIt Anti-Fog Solution, CoStorSol Cold Storage Solution, Jac-cell Medic Anti-Fog Cloth, MaPerSol Organ Preservation Solution, Machine Perfusion Sol'n-Belzer MPS and more

Devices it lists

Device	Product code	Class	Role	Source
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Marker, Colon	NBG	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retention Device, Suture	KGS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Perfusion, Kidney	KDN	2	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
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
October 9, 2002	K022826	CLEAR-IT ANTI-FOG, MODEL PS003	OCT	Substantially Equivalent	Preservation Solutions, Inc.	accessdata.fda.gov
November 18, 1999	K983753	STAR TEMPORARY WOUND COVER	FTL	Substantially Equivalent	Osteogenics, 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
February 26, 2018	79378	Class II	Terminated	Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific or	Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..	accessdata.fda.gov
September 24, 2010	56913	Not yet classified	Terminated	Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufa	Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.	accessdata.fda.gov

Compare with other makers

Updated August 8, 2008. 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.