B. Braun Instruments: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “B. Braun Instruments” (first 1976, latest 1976), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| JCY | Catheter, Infusion | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| KGZ | Accessories, Catheter | 3 | 3 |
| FGY | Cannula, Injection | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GCD | Connector, Catheter | 1 | 1 |
Review panels
Most recent B. Braun Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K760392 | SYRINGES | FMF | 1976-11-02 | 89 |
| K760391 | CATHETER, VEIN (BRAUNULA) | JCY | 1976-11-02 | 89 |
| K760390 | CATHETER, VEIN (BRAUNULA T) | JCY | 1976-11-02 | 89 |
| K760389 | CANNULA, IV | FGY | 1976-11-02 | 89 |
| K760388 | CATHETER, VEIN (VENOFIX) | DQO | 1976-11-02 | 89 |
| K760387 | CATHETER, CAVA (CAVAFIX) | DQO | 1976-11-02 | 89 |
| K760386 | CENTRAL VEINOUS PRESSURE SETS | DQO | 1976-11-02 | 89 |
| K760385 | EXTENSION SETS | KGZ | 1976-11-02 | 89 |
| K760384 | STOPPERS | KGZ | 1976-11-02 | 89 |
| K760383 | STOPCOCKS | KGZ | 1976-11-02 | 89 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B. Braun Instruments.
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 B. Braun Instruments (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
Frequently asked questions
How many FDA 510(k) clearances are listed under B. Braun Instruments?
FDA lists 13 510(k) clearances under the applicant name “B. Braun Instruments” (first 1976, latest 1976), across 6 product codes in 3 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 Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name B. Braun Instruments is 89 days.
Which FDA product codes appear under B. Braun Instruments?
The most frequent FDA product codes under this applicant name are JCY (Catheter, Infusion, 4); DQO (Catheter, Intravascular, Diagnostic, 3); KGZ (Accessories, Catheter, 3).
Next steps
- See all 13 B. Braun Instruments clearances with predicates and recalls
- Run predicate analysis for product code JCY, B. Braun Instruments'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.