Preservation Solutions Inc
Elkhorn, WI, US
PRESERVATION SOLUTIONS, INC. appears in FDA device records in Elkhorn, WI. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Preservation Solutions Inc between 2002 and 2015. The busiest year on record is 2008, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151728 | CoStorSol plus G | KDN | Substantially Equivalent | |
| K091245 | COSTORSOL | KDN | Substantially Equivalent | |
| K083453 | COSTORSOL | KDN | Substantially Equivalent | |
| K080432 | MAPERSOL | KDN | Substantially Equivalent | |
| K073693 | COSTORSOL | KDN | Substantially Equivalent | |
| K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 | OCT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2132588 | 1000221028 | PRESERVATION SOLUTIONS, INC. | 1099 Proctor Dr, ELKHORN, WI 53121 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1387-2018 | 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 organs in preparation for storage, transportation, and transplantation into a recipient. | 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.. | Class II | Terminated | |
| Z-0427-2011 | 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. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201. | Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain