Xpert Carba-R
FDA 510(k) clearance K261867 · decided 2026-07-02
Clearance details
- K-number
- K261867
- Device name
- Xpert Carba-R
- Applicant
- Cepheid®
- Decision
- Substantially Equivalent
- Date received
- 2026-06-04
- Decision date
- 2026-07-02
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- POC
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cepheid®
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD MAX Check-Points CPO (K190613) | Check-Points Health B.V. | 2019-08-29 |
| Xpert Carba-R (K173263) | Cepheid | 2018-01-09 |
| Xpert Carba-R (K160901) | Cepheid | 2016-06-29 |
Recalls involving this device
No recalls on record reference this clearance.