Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BD Diagnostic Systems — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
125 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | 2026-05-28 | 125 | 0 |
| K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) | Bd Diagnostic Systems | 2003-09-15 | 32 | 0 |
| K032153 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 U | Bd Diagnostic Systems | 2003-09-11 | 59 | 0 |
| K032259 | PASCO MIC AND MIC/ID PANELS | Bd Diagnostic Systems | 2003-08-19 | 28 | 0 |
| K031429 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 U | Bd Diagnostic Systems | 2003-06-06 | 31 | 0 |
| K030091 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 | Bd Diagnostic Systems | 2003-02-28 | 49 | 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