Brahms GmbH: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Brahms GmbH” (first 2017, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 23 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 |
|---|---|---|
| 2017 | 1 | 23 |
| 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 Brahms GmbH took a median 23 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PMT | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | 1 | 0 |
| PRI | Procalcitonin Assay | 1 | 1 |
Review panels
- Microbiology (2)
Most recent Brahms GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171338 | B R A H M S PCT sensitive KRYPTOR | PRI | 2017-05-31 | 23 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150009 | De Novo | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | 2016-02-20 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-03-12.
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.
- Brahms Diagnostica, LLC (6 510(k)s)
- Brahms Aktiengesellschaft (2 510(k)s)
- Brahms GmbH, Part of Thermo Fisher Scientific (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brahms GmbH?
FDA lists 1 510(k) clearance under the applicant name “Brahms GmbH” (first 2017, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Brahms GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brahms GmbH is 23 days.
Which FDA product codes appear under Brahms GmbH?
The most frequent FDA product codes under this applicant name are PMT (Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens, 1); PRI (Procalcitonin Assay, 1).
Next steps
- See all 1 Brahms GmbH clearances with predicates and recalls
- Run predicate analysis for product code PMT, Brahms 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.