Prodesse, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Prodesse, Inc.” (first 2008, latest 2009), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 | 0 | — |
| 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 3 | 3 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | 1 | 1 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Prodesse, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091053 | PROPARAFLU+ASSAY | OOU | 2009-11-20 | 221 |
| K092500 | MODIFICATION TO PROFLU+ ASSAY | OCC | 2009-08-20 | 6 |
| K090239 | PROGASTRO CD ASSAY | LLH | 2009-04-16 | 73 |
| K082688 | PRO HMPV+ ASSAY | OEM | 2008-11-07 | 53 |
| K081030 | MODIFICATION TO PROFLU+ ASSAY | OCC | 2008-05-02 | 21 |
| K073029 | PROFLU+ ASSAY | OCC | 2008-01-04 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Prodesse, Inc..
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 Prodesse, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Prodesse, Inc.” (first 2008, latest 2009), across 4 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 Prodesse, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prodesse, Inc. is 60 days.
Which FDA product codes appear under Prodesse, Inc.?
The most frequent FDA product codes under this applicant name are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 3); LLH (Reagents, Clostridium Difficile Toxin, 1); OEM (Human Metapneumovirus (Hmpv) Rna Assay System, 1).
Next steps
- See all 6 Prodesse, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Prodesse, 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.