Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PCI — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
210 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bac | Becton, Dickinson and Company | 2025-10-31 | 266 | 0 |
| K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bact | Becton, Dickinson and Company | 2022-07-28 | 210 | 0 |
| K173330 | PanNAT STEC Test | Micronics, Inc. | 2018-06-01 | 221 | 0 |
| K163571 | Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | 2017-07-12 | 205 | 0 |
| K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | Becton, Dickinson and Company | 2014-05-06 | 111 | 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