Braun GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Braun GmbH” (first 1999, latest 2006), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 33 days. 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 | 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| JEQ | Toothbrush, Powered | 2 | 2 |
Review panels
- General Hospital (3)
- Cardiovascular (2)
- Dental (2)
Most recent Braun GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061351 | ORAL-B SONIC COMPLETE | JEQ | 2006-06-05 | 21 |
| K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | JEQ | 2006-05-31 | 33 |
| K060006 | BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER | FLL | 2006-01-31 | 28 |
| K031928 | BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) | FLL | 2003-10-24 | 123 |
| K012035 | BRAUN PRECISION SENSOR PRO, MODEL BP 2590 | DXN | 2001-07-27 | 28 |
| K003732 | BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES | DXN | 2001-05-16 | 163 |
| K992468 | BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER | FLL | 1999-10-20 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Braun GmbH.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Braun AG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Braun GmbH?
FDA lists 7 510(k) clearances under the applicant name “Braun GmbH” (first 1999, latest 2006), across 3 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 Braun GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Braun GmbH is 33 days.
Which FDA product codes appear under Braun GmbH?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 3); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); JEQ (Toothbrush, Powered, 2).
Next steps
- See all 7 Braun GmbH clearances with predicates and recalls
- Run predicate analysis for product code FLL, Braun GmbH'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.