Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid
Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid (California): 510(k) cleared for Cepheid. Its amount of 155 is above the median of 138 (58th percentile). Dated 40 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-03, 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: 155 · 58th percentile of 414 FDAPulse records · 1.1x 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 | 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 |
| amount percentile | 58th of 414 (median 138, 1.1x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-25
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid and 76 California peers
- California FDAPulse records like this one: 76
- Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid's amount: 58th 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)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 155-day review, longer than typical.
- Posted 40 days ago.
What is the FDAPulse record for Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid in California?
Xpert Respiratory Panel (K261336) by Cepheid was cleared on 2026-09-25 after 155 days of review.
How does Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid compare to other California FDAPulse records?
Its amount of 155 sits in the upper half (58th percentile) of 414 records; the median is 138. It is 40 days old, still within a typical 45-day follow-up window.
Xpert Respiratory Panel (K261336) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Xpert Respiratory Panel (K261336) | CA | 2026-09-25 |
| Xpert Xpress CoV-2/Flu plus (K263333) | CA | 2026-10-22 |
| Xpert Xpress CoV-2/Flu plus (K263120) | CA | 2026-10-02 |
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