Preanalytix GmbH: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Preanalytix GmbH” (first 2009, latest 2023), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 189 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 | 344 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Preanalytix GmbH took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 30 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NTW | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | 2 | 1 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 2 | 2 |
Review panels
- Clinical Chemistry (2)
- Pathology (2)
Most recent Preanalytix GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231469 | PAXgene® Blood DNA Tube | PJE | 2023-06-21 | 30 |
| K142821 | PAXgene Blood DNA Tube | PJE | 2015-09-09 | 344 |
| K082150 | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM | NTW | 2009-02-04 | 189 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN050003 | De Novo | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | 2005-04-18 |
Recalls
openFDA lists no recalls under a recalling firm named Preanalytix 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Preanalytix GmbH?
FDA lists 3 510(k) clearances under the applicant name “Preanalytix GmbH” (first 2009, latest 2023), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Preanalytix GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Preanalytix GmbH is 189 days.
Which FDA product codes appear under Preanalytix GmbH?
The most frequent FDA product codes under this applicant name are NTW (System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test, 2); PJE (Blood/Plasma Collection Device For Dna Testing, 2).
Next steps
- See all 3 Preanalytix GmbH clearances with predicates and recalls
- Run predicate analysis for product code NTW, Preanalytix 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.