BD (Becton, Dickinson and Company): FDA 510(k) clearances across all its applicant names

FDA lists 1,959 510(k) clearances, 16 PMA and 0 De Novo decisions across the 49 applicant names Caduvo groups under BD (Becton, Dickinson and Company), first 1976, latest 2026. Median 510(k) review time across these names: 65 days. Since 2017 the median was 124 days, against 134 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 49 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.

Top product codes

Plus 451 more product codes.

Review panels

• General Hospital (464)
• Microbiology (434)
• Cardiovascular (264)
• Gastroenterology and Urology (222)
• Clinical Chemistry (184)
• General and Plastic Surgery (166)
• Anesthesiology (60)
• Hematology (57)
• Obstetrics and Gynecology (31)
• Radiology (22)
• Clinical Toxicology (17)
• Orthopedic (13)
• Immunology (12)
• Pathology (6)
• Physical Medicine (6)
• Ear, Nose and Throat (2)
• Ophthalmic (2)
• Neurology (1)

Most recent BD (Becton, Dickinson and Company) 510(k) clearances

1,949 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,406 product recalls in 565 recall events under these names; 425 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

C.R. Bard (December 2017; incl. Davol, Bard Access Systems, Bard Peripheral Vascular) and CareFusion (2015; incl. Alaris infusion, whose earlier filings were made under Cardinal Health 303 / Cardinal Health Alaris Products). Includes filings made before each acquisition. Left out: Biosciences and Diagnostic Solutions names (combined with Waters Corporation, February 9, 2026), Bard Electrophysiology (sold to Boston Scientific 2013), CareFusion respiratory names (Vyaire, 2016), BD consumer and diabetes names (Embecta, 2022). Edwards Critical Care (BD since September 2024) filed under Edwards Lifesciences and is not included. The plain BD / BECTON DICKINSON names still contain some pre-2026 diagnostics filings that cannot be split out.

Sources

• https://en.wikipedia.org/wiki/Becton_Dickinson
• https://en.wikipedia.org/wiki/C._R._Bard
• https://en.wikipedia.org/wiki/CareFusion
• https://investors.bd.com/news-events/press-releases/detail/937/bd-completes-combination-of-biosciences-diagnostic-solutions-business-with-waters-corporation

Frequently asked questions

How many FDA 510(k) clearances are listed across BD (Becton, Dickinson and Company)'s applicant names?

FDA lists 1,959 510(k) clearances, 16 PMA and 0 De Novo decisions across the 49 applicant names Caduvo groups under BD (Becton, Dickinson and Company), first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does BD (Becton, Dickinson and Company) file under?

The names with the most 510(k) clearances in this group are C.R. Bard, Inc. (655); Bd Becton Dickinson Vacutainer Systems Preanalytic (632); Becton, Dickinson & CO (196); Becton, Dickinson and Company (135); Davol, Inc. (50). The full list of 49 names is on this page.

How long does FDA take to clear BD (Becton, Dickinson and Company) 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 65 days. Since 2017 the median was 124 days, against 134 days for all cleared 510(k)s in the same product codes.

Does the BD (Becton, Dickinson and Company) count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 1,959 BD (Becton, Dickinson and Company) clearances with predicates and recalls
• Run predicate analysis for product code LON, BD (Becton, Dickinson and Company)'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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