Raumedic AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Raumedic AG” (first 2011, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 106 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 | 1 | 75 |
| 2013 | 1 | 238 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 31 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 210 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Raumedic AG took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 6 | 6 |
Review panels
- Neurology (6)
Most recent Raumedic AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250285 | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL | GWM | 2025-08-29 | 210 |
| K171666 | MPR2 logO DATALOGGER | GWM | 2017-07-06 | 31 |
| K130529 | RAUMEDIC-PTO-MONITORING-SYSTEM | GWM | 2013-10-25 | 238 |
| K120252 | RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM | GWM | 2012-04-11 | 75 |
| K112017 | RAUMEDIC ICP MONITORING SYSTEM | GWM | 2011-10-11 | 89 |
| K103206 | RAUMEDIC- ICP-MONITORING SYSTEM | GWM | 2011-03-04 | 123 |
Recalls
openFDA lists no recalls under a recalling firm named Raumedic 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Raumedic AG?
FDA lists 6 510(k) clearances under the applicant name “Raumedic AG” (first 2011, latest 2025), across 1 product code 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 Raumedic AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Raumedic AG is 106 days.
Which FDA product codes appear under Raumedic AG?
The most frequent FDA product codes under this applicant name are GWM (Device, Monitoring, Intracranial Pressure, 6).
Next steps
- See all 6 Raumedic AG clearances with predicates and recalls
- Run predicate analysis for product code GWM, Raumedic 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 (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.