Data / Medical devices / United States / Organ Recovery Systems, Inc.
Organ Recovery Systems, Inc.: FDA-registered device maker in Itasca, IL, United States, 3 510(k) clearances
Organ Recovery Systems, Inc. is registered with the FDA (registration 3004068499) in Itasca, IL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 11, 2010. 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
- 3004068499
- Address
- One Pierce Place Suite 475W, Itasca, IL, United States, 60143
- Owner or operator
- Organ Recovery Systems, Inc. (9056483)
- Roles
- Manufacturer
- First device listed
- May 20, 2003
- Registered through
- 2026
- Brand names listed
- KPS-1®, Kidney Perfusion Solution, LifePort® Kidney Perfusion Transporter, SPS-1®, Static Preservation Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Perfusion, Kidney, Disposable | KDL | 2 | 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 |
|---|---|---|---|---|---|---|
| March 11, 2010 | K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | KDL | Substantially Equivalent | Organ Recovery Systems, Inc. | accessdata.fda.gov |
| July 31, 2003 | K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | KDN | Substantially Equivalent | Organ Recovery Systems, Inc. | accessdata.fda.gov |
| October 21, 2002 | K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION | KDN | Substantially Equivalent | Organ Recovery Systems, 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 |
|---|---|---|---|---|---|---|
| January 30, 2020 | 84880 | Class II | Terminated | 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, whic | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. | accessdata.fda.gov |
| December 14, 2016 | 75978 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated March 11, 2010. 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.