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Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® vs Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®: FDAPulse comparison
Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®'s review days of 30 is 1.1x Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®'s 28 (10th percentile). Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® is dated 2026-10-02; Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid® 2026-10-22.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® compare to Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®?
| Field | Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® | Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid® |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K263120 | K263333 |
| Device | Xpert Xpress CoV-2/Flu plus | Xpert Xpress CoV-2/Flu plus |
| Applicant | Cepheid® | Cepheid® |
| Specialty / panel | Microbiology | Microbiology |
| Product code | QOF | QOF |
| Device class | 2 | 2 |
| Clearance type | Special | Special |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-09-04 | 2026-09-22 |
| Decision date | 2026-10-02 | 2026-10-22 |
| Review time (days) | 28 | 30 |
| Third-party review | No | No |
| Applicant location | Sunnyvale, CA, US | Sunnyvale, CA, US |
| amount percentile | 6th | 10th |
| Predicate Speed & CAPA Advisory Opportunity Score | 41/100 | 47/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® · Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®
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