Becton, Dickinson and Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Becton, Dickinson and Co.” (first 2001, latest 2015), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 27 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 | 2 | 27 |
| 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 |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 1 | 1 |
Review panels
- General Hospital (3)
- Microbiology (3)
Most recent Becton, Dickinson and Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | PSZ | 2015-10-27 | 27 |
| K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | PSZ | 2015-10-27 | 27 |
| K100005 | BD PEN NEEDLE | FMI | 2010-04-15 | 101 |
| K041572 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML | LON | 2004-08-12 | 59 |
| K010890 | BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) | FMF | 2001-04-19 | 24 |
| K010572 | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE | KKX | 2001-03-12 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Becton, Dickinson and Co..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Becton, Dickinson and Co. (a text match, not an official crosswalk):
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 Company (BD) (5 510(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 Co.?
FDA lists 6 510(k) clearances under the applicant name “Becton, Dickinson and Co.” (first 2001, latest 2015), across 5 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 and Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton, Dickinson and Co. is 27 days.
Which FDA product codes appear under Becton, Dickinson and Co.?
The most frequent FDA product codes under this applicant name are PSZ (Devices Detecting Influenza A, B, And C Virus Antigens, 2); FMF (Syringe, Piston, 1); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 6 Becton, Dickinson and Co. clearances with predicates and recalls
- Run predicate analysis for product code PSZ, Becton, Dickinson and Co.'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.