B. Braun of America, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “B. Braun of America, Inc.” (first 1991, latest 2000), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 186 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 B. Braun, 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 3 | 3 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 3 | 3 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FIE | Needle, Fistula | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (11)
- Anesthesiology (2)
- Cardiovascular (2)
- Gastroenterology and Urology (2)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent B. Braun of America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | LJT | 2000-03-13 | 186 |
| K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 | 147 |
| K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS | FOZ | 1995-11-03 | 319 |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | FIE | 1995-10-06 | 310 |
| K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 | 389 |
| K945752 | CELSITE(TM) BRACHIAL VENOUS PORT | LJT | 1995-05-31 | 189 |
| K945551 | CELSITE(TM) DUAL VENOUS SYSTEM | LJT | 1995-04-21 | 158 |
| K943770 | LOW VOLUME MULTIPORT | FPA | 1995-04-10 | 251 |
| K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE | FCG | 1995-04-04 | 32 |
| K950184 | B. BRAUN IV START KITS | LRS | 1995-03-15 | 57 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B. Braun of America, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under B. Braun of America, Inc.?
FDA lists 19 510(k) clearances under the applicant name “B. Braun of America, Inc.” (first 1991, latest 2000), across 13 product codes in 6 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 B. Braun of America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name B. Braun of America, Inc. is 186 days.
Which FDA product codes appear under B. Braun of America, Inc.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 3); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 3); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 2).
Next steps
- See all 19 B. Braun of America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHI, B. Braun of America, 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.