Cepheid®: FDA clearances and approvals
Cepheid® has 11 FDA 510(k) clearances (first 2023, latest 2026), across 7 product codes in 2 review panels. Median 510(k) review time: 30 days. Since 2017 its median was 30 days, against 147 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 3 | 139 |
| 2024 | 3 | 23 |
| 2025 | 4 | 58 |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, Cepheid®'s cleared 510(k)s 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 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 3 | 3 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | 2 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 2 | 2 |
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species | 1 | 1 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 | 1 |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | 1 | 1 |
Review panels
- Microbiology (10)
- Pathology (1)
Most recent Cepheid® 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261867 | Xpert Carba-R | POC | 2026-07-02 | 28 |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-05-01 | 30 |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2025-05-01 | 30 |
| K243730 | Xpert C. difficile/Epi | OZN | 2025-02-28 | 87 |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | QQX | 2025-01-15 | 180 |
| K243625 | Xpert MRSA/SA SSTI | NQX | 2024-12-18 | 23 |
| K243405 | Xpert vanA | NIJ | 2024-11-21 | 20 |
| K243070 | Xpert® SA Nasal Complete | NQX | 2024-10-25 | 28 |
| K230440 | Xpert® Xpress CoV-2 plus | QQX | 2023-10-13 | 234 |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | 2023-08-17 | 86 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cepheid®.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cepheid® have?
Cepheid® has 11 FDA 510(k) clearances (first 2023, latest 2026), across 7 product codes in 2 review panels.
How long does FDA take to clear Cepheid®'s 510(k)s?
The median time from FDA receipt to decision across Cepheid®'s cleared 510(k)s is 30 days. Since 2017: 30 days, versus 147 days for all cleared 510(k)s in the same product codes.
What devices does Cepheid® make?
Its most frequent FDA product codes are QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 3); NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, 2); QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test, 2).
Has Cepheid® had device recalls?
openFDA lists no recalls under a recalling firm name matching Cepheid®. Related entities may recall under other names.
Next steps
- See all 11 Cepheid® clearances with predicates and recalls
- Run predicate analysis for product code QOF, Cepheid®'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.