Becton, Dickinson and Company: FDA clearances and approvals
Becton, Dickinson and Company has 135 FDA 510(k) clearances (first 2010, latest 2026), plus 1 PMA decision, across 37 product codes in 6 review panels. Median 510(k) review time: 122 days. Since 2017 its median was 192 days, against 161 days for all cleared 510(k)s in the same product codes. openFDA lists 29 product recalls by a recalling firm named Becton, Dickinson and Company. It is the industry lead sponsor of 35 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 106 |
| 2013 | 9 | 34 |
| 2014 | 7 | 97 |
| 2015 | 7 | 40 |
| 2016 | 12 | 134 |
| 2017 | 8 | 52 |
| 2018 | 10 | 113 |
| 2019 | 6 | 210 |
| 2020 | 8 | 175 |
| 2021 | 7 | 254 |
| 2022 | 14 | 208 |
| 2023 | 13 | 267 |
| 2024 | 6 | 174 |
| 2025 | 10 | 148 |
| 2026 | 6 | 167 |
Review time against the same product codes
Since 2017, Becton, Dickinson and Company's cleared 510(k)s took a median 192 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 18 | 18 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 14 | 14 |
| FMF | Syringe, Piston | 13 | 13 |
| FMI | Needle, Hypodermic, Single Lumen | 11 | 11 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 10 | 10 |
| MDB | System, Blood Culturing | 7 | 7 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 | 6 |
| NGT | Saline, Vascular Access Flush | 5 | 5 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 | 5 |
| JTN | Susceptibility Test Discs, Antimicrobial | 4 | 4 |
Plus 27 more product codes.
Review panels
- Microbiology (57)
- General Hospital (49)
- Clinical Chemistry (22)
- Anesthesiology (4)
- Hematology (3)
- General and Plastic Surgery (1)
Most recent Becton, Dickinson and Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | JTZ | 2026-09-14 | 80 |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | JKA | 2026-04-15 | 89 |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | JKA | 2026-04-10 | 245 |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | JKA | 2026-04-10 | 254 |
| K260184 | Onclarity Self-Collection Kit | SEP | 2026-04-02 | 71 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | JKA | 2026-03-13 | 256 |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | NGT | 2025-12-02 | 253 |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | PCI | 2025-10-31 | 266 |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | ONB | 2025-09-12 | 245 |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | LON | 2025-08-08 | 66 |
125 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160037 | PMA | BD ONCLARITY HPV ASSAY | 2018-02-12 |
Recalls
29 product recalls in 12 recall events; 4 initiated in the last five years. Most recent: 2026-08-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Becton, Dickinson and Company is the industry lead sponsor of 35 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06632509: BD SiteRite(TM) 9 Ultrasound System - Clinical Study (Completed, started 2025-11-12)
- NCT06632496: BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study (Completed, started 2025-03-28)
- NCT06604026: Investigational Study With the BD PosiFlush™ SafeScrub on NADs (Completed, started 2024-10-22)
- NCT05953363: Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories. (Completed, started 2023-07-24)
- NCT05763147: Study of BD Pre-filled Flush Syringes in China (Completed, started 2022-11-03)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Becton, Dickinson and Company's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Becton, Dickinson and Company have?
Becton, Dickinson and Company has 135 FDA 510(k) clearances (first 2010, latest 2026), plus 1 PMA decision, across 37 product codes in 6 review panels.
How long does FDA take to clear Becton, Dickinson and Company's 510(k)s?
The median time from FDA receipt to decision across Becton, Dickinson and Company's cleared 510(k)s is 122 days. Since 2017: 192 days, versus 161 days for all cleared 510(k)s in the same product codes.
What devices does Becton, Dickinson and Company make?
Its most frequent FDA product codes are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 18); LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 14); FMF (Syringe, Piston, 13).
Has Becton, Dickinson and Company had device recalls?
openFDA lists 29 product recalls in 12 recall events by a recalling firm whose name matches Becton, Dickinson and Company; the most recent began 2026-08-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 135 Becton, Dickinson and Company clearances with predicates and recalls
- Run predicate analysis for product code JKA, Becton, Dickinson and Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.