Company ยท US
Organ Recovery Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2010. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 2010 | K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L Organ Recovery Systems, Inc. | KDL |
| Jul 31, 2003 | K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) Organ Recovery Systems, Inc. | KDN |
| Oct 21, 2002 | K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION Organ Recovery Systems, Inc. | KDN |
| Jan 25, 2002 | K013575 | KPS-I, THE KIDNEY PERFUSION SOLUTION Organ Recovery Systems, Inc. | KDN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2020 | Organ Recovery Systems, Inc. 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 tr Terminated |
KDN | K021362 |
| Dec 14, 2016 | Organ Recovery Systems, Inc. SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 Terminated |
KDL | K091656 |