Becton Dickinson Infusion Therapy Systems, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Becton Dickinson Infusion Therapy Systems, Inc.” (first 1997, latest 2026), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 103 days, against 135 days for all cleared 510(k)s in the same product codes. 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 | 1 | 43 |
| 2014 | 0 | — |
| 2015 | 2 | 72 |
| 2016 | 1 | 61 |
| 2017 | 1 | 51 |
| 2018 | 0 | — |
| 2019 | 1 | 103 |
| 2020 | 2 | 113 |
| 2021 | 0 | — |
| 2022 | 1 | 30 |
| 2023 | 3 | 147 |
| 2024 | 0 | — |
| 2025 | 6 | 122 |
| 2026 | 1 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Becton Dickinson Infusion Therapy Systems, Inc. took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 30 | 30 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- General Hospital (32)
- Clinical Chemistry (2)
- Cardiovascular (1)
- Immunology (1)
Most recent Becton Dickinson Infusion Therapy Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252137 | BD Insyte IV Catheter | FOZ | 2026-04-02 | 268 |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter System | FOZ | 2025-10-08 | 154 |
| K243403 | BD Nexiva Closed IV Catheter System | FOZ | 2025-07-25 | 267 |
| K251155 | BD Cathena Safety IV Catheter | FOZ | 2025-07-11 | 88 |
| K251654 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter | FOZ | 2025-06-27 | 28 |
| K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | FOZ | 2025-06-03 | 89 |
| K241586 | PIVO Pro Needle-free Blood Collection Device | JKA | 2025-02-27 | 269 |
| K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | FOZ | 2023-12-01 | 29 |
| K230865 | PIVO Pro Needle-free Blood Collection Device | JKA | 2023-09-28 | 183 |
| K231239 | Nexiva Closed IV Catheter System with NearPort IV Access | FOZ | 2023-09-22 | 147 |
26 earlier clearances. See the full list in Caduvo.
Recalls
15 product recalls in 7 recall events; 14 initiated in the last five years. Most recent: 2025-05-21.
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 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 Infusion Therapy Systems, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Becton Dickinson Infusion Therapy Systems, Inc.” (first 1997, latest 2026), across 5 product codes in 4 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 Infusion Therapy Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Infusion Therapy Systems, Inc. is 90 days. Since 2017: 103 days, versus 135 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Becton Dickinson Infusion Therapy Systems, Inc.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 30); FPA (Set, Administration, Intravascular, 2); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 2).
Next steps
- See all 36 Becton Dickinson Infusion Therapy Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Becton Dickinson Infusion Therapy Systems, 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.