Becton Dickinson Diagnostic Instrument Systems: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Becton Dickinson Diagnostic Instrument Systems” (first 1995, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 113 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MDB | System, Blood Culturing | 8 | 8 |
| GKZ | Counter, Differential Cell | 4 | 4 |
| JTA | Monitor, Microbial Growth | 1 | 1 |
Review panels
- Microbiology (9)
- Hematology (4)
Most recent Becton Dickinson Diagnostic Instrument Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954923 | BACTEC FUNGAL MEDIUM | JTA | 1996-11-21 | 392 |
| K954932 | BBL MGIT PRODUCTS | MDB | 1996-08-21 | 299 |
| K962210 | BACTEC 9050 SYSTEM | MDB | 1996-08-08 | 59 |
| K946268 | BACTEC(R) 9000TB SYSTEM | MDB | 1996-05-21 | 515 |
| K960827 | QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) | GKZ | 1996-05-17 | 78 |
| K954930 | BACTEC CULTURE VIALS, LYTIC, ANAEROBIC | MDB | 1996-02-16 | 113 |
| K954927 | BACTEC PEDS PLUS/F CULTURE VIALS | MDB | 1996-02-16 | 113 |
| K954925 | BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS | MDB | 1996-02-16 | 113 |
| K954921 | BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS | MDB | 1996-02-16 | 113 |
| K954924 | BACTEC PEDS PLUS CLUTURE VIALS | MDB | 1996-02-08 | 105 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Becton Dickinson Diagnostic Instrument Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Becton, Dickinson & CO (340 510(k)s)
- Becton Dickinson Infusion Therapy Systems, Inc. (36 510(k)s)
- Becton Dickinson Microbiology Systems (33 510(k)s)
- Becton Dickinson Vascular Access, Inc. (25 510(k)s)
- Becton Dickinson Immunocytometry Systems (21 510(k)s)
- Becton Dickinson Vacutainer Systems (15 510(k)s)
- Becton Dickinson Advanced Diagnostics (10 510(k)s)
- Becton, Dickinson and Company (BD) (5 510(k)s)
- Becton Dickinson Consumer Products (3 510(k)s)
- Becton Dickinson Labware (3 510(k)s)
- Becton, Dickinson and Company (Bard Access Systems, Inc.) (1 510(k)s)
- Becton Dickinson Biosciences (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Becton Dickinson Diagnostic Instrument Systems?
FDA lists 13 510(k) clearances under the applicant name “Becton Dickinson Diagnostic Instrument Systems” (first 1995, latest 1996), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Becton Dickinson Diagnostic Instrument Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Diagnostic Instrument Systems is 113 days.
Which FDA product codes appear under Becton Dickinson Diagnostic Instrument Systems?
The most frequent FDA product codes under this applicant name are MDB (System, Blood Culturing, 8); GKZ (Counter, Differential Cell, 4); JTA (Monitor, Microbial Growth, 1).
Next steps
- See all 13 Becton Dickinson Diagnostic Instrument Systems clearances with predicates and recalls
- Run predicate analysis for product code MDB, Becton Dickinson Diagnostic Instrument Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.