Becton, Dickinson and Company (BD): FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Becton, Dickinson and Company (BD)” (first 2009, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 105 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under BD (Becton, Dickinson and Company), based on public ownership records.
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 | 75 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Becton, Dickinson and Company (BD) took a median 75 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FQH | Lavage, Jet | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JTN | Susceptibility Test Discs, Antimicrobial | 1 | 1 |
Review panels
- General Hospital (3)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Becton, Dickinson and Company (BD) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | FQH | 2026-02-25 | 75 |
| K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | JTN | 2011-10-18 | 42 |
| K111366 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | FOZ | 2011-09-30 | 137 |
| K110105 | BD PEN NEEDLE | FMI | 2011-04-28 | 105 |
| K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | JKA | 2009-08-25 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Becton, Dickinson and Company (BD).
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 (196 510(k)s)
- Becton, Dickinson and Company (135 510(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 Diagnostic Instrument Systems (13 510(k)s)
- Becton Dickinson Advanced Diagnostics (10 510(k)s)
- Becton, Dickinson and Co. (6 510(k)s)
- Becton Dickinson & Company (3 510(k)s)
- Becton Dickinson Consumer Products (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Becton, Dickinson and Company (BD)?
FDA lists 5 510(k) clearances under the applicant name “Becton, Dickinson and Company (BD)” (first 2009, latest 2026), across 5 product codes in 3 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 and Company (BD)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton, Dickinson and Company (BD) is 105 days.
Which FDA product codes appear under Becton, Dickinson and Company (BD)?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); FQH (Lavage, Jet, 1).
Next steps
- See all 5 Becton, Dickinson and Company (BD) clearances with predicates and recalls
- Run predicate analysis for product code FMI, Becton, Dickinson and Company (BD)'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.