Bruker Daltonik GmbH: FDA clearances and approvals
Bruker Daltonik GmbH has 2 FDA 510(k) clearances (first 2017, latest 2020), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time: 303 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 222 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 384 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bruker Daltonik GmbH's cleared 510(k)s took a median 303 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 246 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PEX | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 1 | 1 |
| QBN | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 1 | 0 |
| QNJ | Mass Spectrometry, Microorganism Identification, Blood Culture | 1 | 1 |
Review panels
- Microbiology (3)
Most recent Bruker Daltonik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193419 | MBT Sepsityper | QNJ | 2020-12-27 | 384 |
| K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | PEX | 2017-07-26 | 222 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170081 | De Novo | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 2018-04-20 |
Recalls
openFDA lists no recalls under a recalling firm named Bruker Daltonik GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bruker Daltonik GmbH have?
Bruker Daltonik GmbH has 2 FDA 510(k) clearances (first 2017, latest 2020), plus 1 De Novo decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Bruker Daltonik GmbH's 510(k)s?
The median time from FDA receipt to decision across Bruker Daltonik GmbH's cleared 510(k)s is 303 days.
What devices does Bruker Daltonik GmbH make?
Its most frequent FDA product codes are PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates, 1); QBN (Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates, 1); QNJ (Mass Spectrometry, Microorganism Identification, Blood Culture, 1).
Has Bruker Daltonik GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Bruker Daltonik GmbH. Related entities may recall under other names.
Next steps
- See all 2 Bruker Daltonik GmbH clearances with predicates and recalls
- Run predicate analysis for product code PEX, Bruker Daltonik GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.