Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
POC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261867 | Xpert Carba-R | Cepheid® | 2026-07-02 | 28 | 0 |
| K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | 2019-08-29 | 171 | 0 |
| K173263 | Xpert Carba-R | Cepheid | 2018-01-09 | 90 | 0 |
| K160901 | Xpert Carba-R | Cepheid | 2016-06-29 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda