Cepheid: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Cepheid” (first 2006, latest 2026), plus 3 De Novo decisions, across 24 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Since 2017 the median was 162 days, against 125 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.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 116 |
| 2013 | 1 | 80 |
| 2014 | 2 | 100 |
| 2015 | 3 | 128 |
| 2016 | 4 | 86 |
| 2017 | 4 | 169 |
| 2018 | 5 | 91 |
| 2019 | 3 | 87 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 3 | 209 |
| 2023 | 2 | 276 |
| 2024 | 0 | — |
| 2025 | 2 | 103 |
| 2026 | 3 | 102 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cepheid took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 8 | 8 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 8 | 8 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 5 | 5 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 3 | 3 |
| LSL | Dna-Reagents, Neisseria | 2 | 2 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 | 2 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2 | 2 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | 2 |
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | 2 | 1 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | 2 |
Plus 14 more product codes.
Review panels
- Microbiology (47)
- Pathology (3)
Most recent Cepheid 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261362 | Xpert Hemorrhagic Fever | QVR | 2026-08-07 | 102 |
| K253653 | Xpert Hemorrhagic Fever | — | 2026-02-20 | 92 |
| K251721 | Xpert GI Panel | PCH | 2026-01-16 | 226 |
| K250218 | Xpert® FII & FV | NPR | 2025-02-21 | 28 |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-01-10 | 178 |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | PQA | 2023-10-19 | 160 |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | NJR | 2023-09-27 | 391 |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | 2022-06-07 | 47 |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | NJR | 2022-05-09 | 535 |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | 2022-02-09 | 209 |
38 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240016 | De Novo | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test | 2024-06-27 |
| DEN130032 | De Novo | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | 2013-07-25 |
| DEN070004 | De Novo | Assay, Enterovirus Nucleic Acid | 2007-03-16 |
Recalls
19 product recalls in 15 recall events; 7 initiated in the last five years. Most recent: 2025-11-05.
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 Cepheid is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03421626: Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML) (Completed, started 2017-11-08)
- NCT03125460: Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer (Completed, started 2016-12)
- NCT02461576: Clinical Evaluation of the Xpert® HIV-1 VL (Completed, started 2015-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cepheid?
FDA lists 48 510(k) clearances under the applicant name “Cepheid” (first 2006, latest 2026), plus 3 De Novo decisions, across 24 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 Cepheid?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cepheid is 92 days. Since 2017: 162 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cepheid?
The most frequent FDA product codes under this applicant name are NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, 8); OCC (Respiratory Virus Panel Nucleic Acid Assay System, 8); NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, 5).
Next steps
- See all 48 Cepheid clearances with predicates and recalls
- Run predicate analysis for product code NQX, Cepheid'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.