Becton, Dickinson & CO: FDA filings under this applicant name

FDA lists 196 510(k) clearances under the applicant name “Becton, Dickinson & CO” (first 2001, latest 2025), across 33 product codes in 6 review panels. Median 510(k) review time under this name: 52 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Becton, Dickinson & CO took a median 244 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 177 days.

Top product codes

Plus 23 more product codes.

Review panels

• Microbiology (147)
• General Hospital (29)
• Clinical Chemistry (16)
• Ophthalmic (2)
• Anesthesiology (1)
• Hematology (1)

Most recent Becton, Dickinson & CO 510(k) clearances

186 earlier clearances. See the full list in Caduvo.

Recalls

248 product recalls in 115 recall events; 73 initiated in the last five years. Most recent: 2026-04-07.

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.

SEC filings

BECTON DICKINSON & CO (BDX): EDGAR filings, CIK 10795. An SEC registrant with the same name, matched by name only.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Becton, Dickinson & CO (a text match, not an official crosswalk):

• G0008 — Administration of influenza virus vaccine (via PSZ)

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 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 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 & CO?

FDA lists 196 510(k) clearances under the applicant name “Becton, Dickinson & CO” (first 2001, latest 2025), across 33 product codes in 6 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 & CO?

The median time from FDA receipt to decision across 510(k)s cleared under the name Becton, Dickinson & CO is 52 days.

Which FDA product codes appear under Becton, Dickinson & CO?

The most frequent FDA product codes under this applicant name are LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 106); FMI (Needle, Hypodermic, Single Lumen, 10); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 8).

Next steps

• See all 196 Becton, Dickinson & CO clearances with predicates and recalls
• Run predicate analysis for product code LON, Becton, Dickinson & 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.

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