Curetis GmbH: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Curetis GmbH” (first 2019, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 150 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 |
|---|---|---|
| 2019 | 1 | 150 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Curetis GmbH took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QBH | Lower Respiratory Microbial Nucleic Acid Detection System | 2 | 1 |
Review panels
- Microbiology (2)
Most recent Curetis GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191967 | Unyvero LRT BAL Application | QBH | 2019-12-20 | 150 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170047 | De Novo | Lower Respiratory Microbial Nucleic Acid Detection System | 2018-04-03 |
Recalls
openFDA lists no recalls under a recalling firm named Curetis GmbH.
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.
Device clinical trials
An industry sponsor named Curetis GmbH is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01922024: Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application (Completed, started 2015-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Curetis GmbH?
FDA lists 1 510(k) clearance under the applicant name “Curetis GmbH” (first 2019, latest 2019), plus 1 De Novo decision, across 1 product code 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 Curetis GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Curetis GmbH is 150 days.
Which FDA product codes appear under Curetis GmbH?
The most frequent FDA product codes under this applicant name are QBH (Lower Respiratory Microbial Nucleic Acid Detection System, 2).
Next steps
- See all 1 Curetis GmbH clearances with predicates and recalls
- Run predicate analysis for product code QBH, Curetis GmbH'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.