# Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261336 |
| Device | Xpert Respiratory Panel |
| Applicant | Cepheid |
| Specialty / panel | Microbiology |
| Product code | QOF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-23 |
| Decision date | 2026-09-25 |
| Review time (days) | 155 |
| Third-party review | No |
| Applicant location | Sunnyvale, CA, US |

## Why this score
- 155-day review, longer than typical.
- Posted 40 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261336). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.