Organ Recovery Systems, Inc.
Itasca, IL, US
ORGAN RECOVERY SYSTEMS, INC. appears in FDA device records in Itasca, IL. FDA records list 4 510(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 4 510(k) clearances for Organ Recovery Systems, Inc. between 2002 and 2010. The busiest year on record is 2002, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 2 |
| 2003 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | KDL | Substantially Equivalent | |
| K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | KDN | Substantially Equivalent | |
| K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION | KDN | Substantially Equivalent | |
| K013575 | KPS-I, THE KIDNEY PERFUSION SOLUTION | KDN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004068499 | 3004068499 | ORGAN RECOVERY SYSTEMS, INC. | One Pierce Place, Itasca, IL 60143 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-1437-2020 | LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient. | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. | Class II | Terminated | |
| Z-1111-2017 | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 | Organ preservation fluid recalled due to potential for bacterial contamination. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain