Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Preservation Solutions, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
185 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151728 | CoStorSol plus G | Preservation Solutions, Inc. | 2015-09-18 | 84 | 0 |
| K091245 | COSTORSOL | Preservation Solutions, Inc. | 2009-06-17 | 50 | 0 |
| K083453 | COSTORSOL | Preservation Solutions, Inc. | 2009-01-21 | 61 | 0 |
| K080432 | MAPERSOL | Preservation Solutions, Inc. | 2008-08-08 | 171 | 0 |
| K073693 | COSTORSOL | Preservation Solutions, Inc. | 2008-07-03 | 185 | 1 |
| K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 | Preservation Solutions, Inc. | 2002-10-09 | 44 | 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