QIAGEN GmbH: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “QIAGEN GmbH” (first 2012, latest 2026), plus 7 PMA decisions, across 8 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 114 days for all cleared 510(k)s in the same product codes. 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 | 2 | 88 |
| 2013 | 0 | — |
| 2014 | 1 | 102 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 148 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 4 | 158 |
| 2025 | 4 | 58 |
| 2026 | 2 | 154 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name QIAGEN GmbH took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | 7 | 0 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 | 5 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 3 | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | 2 |
| OOI | Real Time Nucleic Acid Amplification System | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 | 1 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 1 | 1 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 1 | 1 |
Review panels
- Microbiology (13)
- Pathology (7)
- Clinical Chemistry (1)
Most recent QIAGEN GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | PAM | 2026-08-06 | 226 |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | 2026-03-09 | 83 |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | 2025-10-22 | 89 |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QOF | 2025-08-27 | 226 |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | PCH | 2025-02-28 | 23 |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | PCH | 2025-01-08 | 28 |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | PLO | 2024-10-29 | 90 |
| K242353 | QIAstat-Dx Respiratory Panel Mini | QOF | 2024-10-25 | 78 |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | PCH | 2024-05-31 | 872 |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | QOF | 2024-05-10 | 227 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210002 | PMA | therascreen PDGFRA RGQ PCR Kit | 2023-06-29 |
| P190026 | PMA | therascreen BRAF V600E RGQ PCR Kit | 2020-04-15 |
| P190001 | PMA | therascreen PIK3CA RGQ PCR Kit | 2019-05-24 |
| P190004 | PMA | therascreen PIK3CA RGQ PCR Kit | 2019-05-24 |
| P180043 | PMA | therascreen FGFR RGQ RT-PCR Kit | 2019-04-12 |
Recalls
5 product recalls in 4 recall events; 4 initiated in the last five years. Most recent: 2023-08-22.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Qiagen, Inc. (2 510(k)s)
- Qiagen Gaithersburg, Inc. (0 510(k)s)
- QIAGEN Manchester, Ltd. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under QIAGEN GmbH?
FDA lists 14 510(k) clearances under the applicant name “QIAGEN GmbH” (first 2012, latest 2026), plus 7 PMA decisions, across 8 product codes in 3 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 QIAGEN GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name QIAGEN GmbH is 90 days. Since 2017: 90 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under QIAGEN GmbH?
The most frequent FDA product codes under this applicant name are OWD (Somatic Gene Mutation Detection System, 7); PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, 5); QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 3).
Next steps
- See all 14 QIAGEN GmbH clearances with predicates and recalls
- Run predicate analysis for product code OWD, QIAGEN 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.