B.Braun Melsungen AG: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “B.Braun Melsungen AG” (first 2011, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 149 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 | 1 | 91 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 223 |
| 2017 | 1 | 149 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name B.Braun Melsungen AG took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
Review panels
- General Hospital (4)
- Cardiovascular (1)
Most recent B.Braun Melsungen AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163358 | Introcan Safety 3 Closed IV Catheter | FOZ | 2017-04-28 | 149 |
| K152050 | Pencylcap | FMI | 2016-03-02 | 223 |
| K131040 | EXTAVIPRO STERICAN 30G | FMI | 2013-07-15 | 91 |
| K111236 | INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 | FOZ | 2011-08-30 | 120 |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | DRS | 2011-04-07 | 262 |
Recalls
openFDA lists no recalls under a recalling firm named B.Braun Melsungen AG.
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.
Device clinical trials
An industry sponsor named B.Braun Melsungen AG is the lead sponsor of 19 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05124821: Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed (Completed, started 2023-05-19)
- NCT04470934: SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF) (Active not recruiting, started 2021-04-30)
- NCT04649931: Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease) (Completed, started 2020-12-14)
- NCT04556318: Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19) (Completed, started 2020-09-23)
- NCT03809715: Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF) (Completed, started 2019-01-17)
Frequently asked questions
How many FDA 510(k) clearances are listed under B.Braun Melsungen AG?
FDA lists 5 510(k) clearances under the applicant name “B.Braun Melsungen AG” (first 2011, latest 2017), across 3 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 B.Braun Melsungen AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name B.Braun Melsungen AG is 149 days.
Which FDA product codes appear under B.Braun Melsungen AG?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); DRS (Transducer, Blood-Pressure, Extravascular, 1).
Next steps
- See all 5 B.Braun Melsungen AG clearances with predicates and recalls
- Run predicate analysis for product code FMI, B.Braun Melsungen AG'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.