Becton Dickinson Vascular Access, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Becton Dickinson Vascular Access, Inc.” (first 1992, latest 1997), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 83 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 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 11 | 11 |
| FPA | Set, Administration, Intravascular | 5 | 5 |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 2 |
| GBX | Catheter, Irrigation | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FOS | Catheter, Umbilical Artery | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
Review panels
Most recent Becton Dickinson Vascular Access, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971339 | INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS | FOZ | 1997-12-24 | 258 |
| K970259 | E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET | FPA | 1997-04-08 | 75 |
| K964050 | FIRST MIDCATH CATHETER | FOZ | 1997-01-06 | 89 |
| K964049 | FIRST MIDCATH CATHETER WITH DUAL LUMENS | FOZ | 1997-01-06 | 89 |
| K964048 | FIRST MIDCATH CATHETER KIT | FOZ | 1997-01-06 | 89 |
| K954906 | FIRST PICC INTRODUCER CATHETER | DYB | 1996-04-08 | 166 |
| K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | FOZ | 1995-07-31 | 39 |
| K952757 | ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER | FOZ | 1995-07-31 | 45 |
| K952053 | E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS | FPA | 1995-05-31 | 30 |
| K950301 | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS | FOZ | 1995-04-18 | 83 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Becton Dickinson Vascular Access, Inc..
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 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 Vascular Access, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Becton Dickinson Vascular Access, Inc.” (first 1992, latest 1997), across 9 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 Vascular Access, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Vascular Access, Inc. is 83 days.
Which FDA product codes appear under Becton Dickinson Vascular Access, Inc.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 11); FPA (Set, Administration, Intravascular, 5); DXO (Transducer, Pressure, Catheter Tip, 2).
Next steps
- See all 25 Becton Dickinson Vascular Access, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Becton Dickinson Vascular Access, Inc.'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.