Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PMY · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191288 | Acuitas AMR Gene Panel | Opgen, Inc. | 2021-09-30 | 871 | 0 |
| K190275 | GenePOC Carba | Genepoc, Inc. | 2019-05-10 | 91 | 0 |
| K152614 | Xpert Carba-R | Cepheid | 2016-03-07 | 175 | 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