FDA applicant
QIAGEN GmbH
FDA records 29 decisions for QIAGEN GmbH (Hilden, DE) from 1988 to 2026: 17 510(k) clearances, 1 De Novo grant and 11 original PMA approvals. Most are in product codes OWD (Somatic Gene Mutation Detection System) and PCH (Gastrointestinal Pathogen Panel Multiplex…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 10 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “Qiagen, Inc.”, “Qiagen”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided QIAGEN GmbH’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like QIAGEN GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “QIAGEN”
FDA records each applicant name separately; these may or may not be the same firm.