Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Organ Recovery Systems, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, S | Organ Recovery Systems, Inc. | 2010-03-11 | 275 | 0 |
| K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | Organ Recovery Systems, Inc. | 2003-07-31 | 457 | 0 |
| K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION | Organ Recovery Systems, Inc. | 2002-10-21 | 90 | 0 |
| K013575 | KPS-I, THE KIDNEY PERFUSION SOLUTION | Organ Recovery Systems, Inc. | 2002-01-25 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda