FDA applicant
Cepheid
FDA records 65 decisions for Cepheid (Sunnyvale, CA) from 2006 to 2026: 62 510(k) clearances and 3 De Novo grants. Most are in product codes NQX (System, Nucleic Acid Amplification Test, Dna…) and OCC (Respiratory Virus Panel Nucleic Acid Assay…). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 88 predicates, 41 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “Cepheid®”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cepheid’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
3in 2025
Class I Class II/III not classified
Planning a device like Cepheid’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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