Preservation Solutions, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Preservation Solutions, Inc.” (first 2002, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 84 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | 5 | 5 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 | 1 |
Review panels
Most recent Preservation Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151728 | CoStorSol plus G | KDN | 2015-09-18 | 84 |
| K091245 | COSTORSOL | KDN | 2009-06-17 | 50 |
| K083453 | COSTORSOL | KDN | 2009-01-21 | 61 |
| K080432 | MAPERSOL | KDN | 2008-08-08 | 171 |
| K073693 | COSTORSOL | KDN | 2008-07-03 | 185 |
| K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 | OCT | 2002-10-09 | 44 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-02-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Preservation Solutions, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Preservation Solutions, Inc.” (first 2002, latest 2015), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Preservation Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Preservation Solutions, Inc. is 72 days.
Which FDA product codes appear under Preservation Solutions, Inc.?
The most frequent FDA product codes under this applicant name are KDN (System, Perfusion, Kidney, 5); OCT (Anti Fog Solution And Accessories, Endoscopy, 1).
Next steps
- See all 6 Preservation Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDN, Preservation Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.