Bd Diagnostic Systems: FDA clearances and approvals
Bd Diagnostic Systems has 6 FDA 510(k) clearances (first 2003, latest 2026), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time: 40 days. openFDA lists 13 product recalls by a recalling firm named Bd Diagnostic Systems.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 125 |
Review time against the same product codes
Since 2017, Bd Diagnostic Systems's cleared 510(k)s took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 3 | 3 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 2 |
| MDB | System, Blood Culturing | 1 | 1 |
| MKQ | Processor, Cervical Cytology Slide, Automated | 1 | 0 |
Review panels
- Microbiology (6)
- Pathology (1)
Most recent Bd Diagnostic Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260213 | BD BACTEC FXI Culture System | MDB | 2026-05-28 | 125 |
| K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) | JWY | 2003-09-15 | 32 |
| K032153 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML | LON | 2003-09-11 | 59 |
| K032259 | PASCO MIC AND MIC/ID PANELS | JWY | 2003-08-19 | 28 |
| K031429 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML | LON | 2003-06-06 | 31 |
| K030091 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML | LON | 2003-02-28 | 49 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970018 | PMA | BD PREPSTAIN SYSTEM | 1999-06-17 |
Recalls
13 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-10-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bd Diagnostic Systems have?
Bd Diagnostic Systems has 6 FDA 510(k) clearances (first 2003, latest 2026), plus 1 PMA decision, across 4 product codes in 2 review panels.
How long does FDA take to clear Bd Diagnostic Systems's 510(k)s?
The median time from FDA receipt to decision across Bd Diagnostic Systems's cleared 510(k)s is 40 days.
What devices does Bd Diagnostic Systems make?
Its most frequent FDA product codes are LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 3); JWY (Manual Antimicrobial Susceptibility Test Systems, 2); MDB (System, Blood Culturing, 1).
Has Bd Diagnostic Systems had device recalls?
openFDA lists 13 product recalls in 1 recall event by a recalling firm whose name matches Bd Diagnostic Systems; the most recent began 2004-10-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Bd Diagnostic Systems clearances with predicates and recalls
- Run predicate analysis for product code LON, Bd Diagnostic Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.