Becton Dickinson Vacutainer Systems: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Becton Dickinson Vacutainer Systems” (first 1995, latest 2000), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 11 | 11 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 1 | 1 |
Review panels
- Clinical Chemistry (14)
- General Hospital (1)
Most recent Becton Dickinson Vacutainer Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | JKA | 2000-11-02 | 84 |
| K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | JKA | 1999-07-28 | 70 |
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | 1999-05-28 | 57 |
| K991120 | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | JKA | 1999-05-19 | 47 |
| K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | 1998-10-28 | 99 |
| K982922 | VACUTAINER BRAND BLOOD COLLECTION SYRINGE | JKA | 1998-09-22 | 34 |
| K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | JKA | 1998-06-17 | 91 |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | PJE | 1998-02-24 | 266 |
| K980098 | VACUTAINER BRAND PRONTO NEEDLES HOLDER | JKA | 1998-02-05 | 24 |
| K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | GIM | 1997-06-17 | 57 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Becton Dickinson Vacutainer Systems.
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 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 Vacutainer Systems?
FDA lists 15 510(k) clearances under the applicant name “Becton Dickinson Vacutainer Systems” (first 1995, latest 2000), across 4 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 Vacutainer Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Vacutainer Systems is 58 days.
Which FDA product codes appear under Becton Dickinson Vacutainer Systems?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 11); GIM (Tubes, Vacuum Sample, With Anticoagulant, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 15 Becton Dickinson Vacutainer Systems clearances with predicates and recalls
- Run predicate analysis for product code JKA, Becton Dickinson Vacutainer Systems'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.