Bd: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Bd” (first 2001, latest 2026), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 118 days, against 177 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 28 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 144 |
| 2023 | 2 | 118 |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 1 | 141 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bd took a median 118 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
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| FQH | Lavage, Jet | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DTK | Filter, Intravascular, Cardiovascular | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (9)
- Microbiology (4)
- Anesthesiology (1)
- Cardiovascular (1)
Most recent Bd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | FQH | 2026-02-20 | 141 |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | DTK | 2024-02-29 | 29 |
| K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit | PSZ | 2023-12-05 | 116 |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | PSZ | 2023-01-27 | 120 |
| K221504 | BD Surgiphor Antimicrobial Irrigation System | FQH | 2022-10-14 | 144 |
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | PSZ | 2018-03-20 | 28 |
| K024240 | BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS | JSM | 2003-03-26 | 93 |
| K023752 | BD INTEGRA SYRINGE | FMF | 2003-02-07 | 91 |
| K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | 2002-07-19 | 72 |
| K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | SCL | 2002-03-20 | 29 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bd.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Bd (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Bd?
FDA lists 15 510(k) clearances under the applicant name “Bd” (first 2001, latest 2026), across 11 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 Bd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bd is 72 days. Since 2017: 118 days, versus 177 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bd?
The most frequent FDA product codes under this applicant name are PSZ (Devices Detecting Influenza A, B, And C Virus Antigens, 3); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); FQH (Lavage, Jet, 2).
Next steps
- See all 15 Bd clearances with predicates and recalls
- Run predicate analysis for product code PSZ, Bd'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.