Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®
Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® (California): 510(k) cleared for Cepheid®. Its amount of 28 is below the median of 138 (6th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263120 |
| Device | Xpert Xpress CoV-2/Flu plus |
| Applicant | Cepheid® |
| Specialty / panel | Microbiology |
| Product code | QOF |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-04 |
| Decision date | 2026-10-02 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Sunnyvale, CA, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-02
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® and 76 California peers
- California FDAPulse records like this one: 76
- Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®'s amount: 6th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 33 days ago.
What is the FDAPulse record for Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® in California?
Xpert Xpress CoV-2/Flu plus (K263120) by Cepheid® was cleared on 2026-10-02 after 28 days of review.
How does Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® compare to other California FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 33 days old, still within a typical 45-day follow-up window.
Xpert Xpress CoV-2/Flu plus (K263120) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Xpert Xpress CoV-2/Flu plus (K263120) | CA | 2026-10-02 |
| Xpert Respiratory Panel (K261336) | CA | 2026-09-25 |
| Xpert Xpress CoV-2/Flu plus (K263333) | CA | 2026-10-22 |
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