Somatex Medical Technologies GmbH: FDA clearances and approvals
Somatex Medical Technologies GmbH has 7 FDA 510(k) clearances (first 2008, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time: 140 days. Since 2017 its median was 90 days, against 123 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Somatex Medical Technologies GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 60 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 227 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Somatex Medical Technologies GmbH's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 6 | 6 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
Most recent Somatex Medical Technologies GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | NEU | 2021-02-18 | 227 |
| K182082 | Tumark for Eviva, Tumark for Brevera | NEU | 2018-10-31 | 90 |
| K180443 | Tumark Vision | NEU | 2018-03-22 | 30 |
| K111692 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC | NEU | 2011-11-08 | 145 |
| K102771 | BIOPSY HANDY, MRI BIOPSY HANDY | KNW | 2011-06-24 | 273 |
| K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | NEU | 2010-02-17 | 140 |
| K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | NEU | 2008-03-19 | 139 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2021-02-03.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Somatex Medical Technologies GmbH's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Somatex Medical Technologies GmbH have?
Somatex Medical Technologies GmbH has 7 FDA 510(k) clearances (first 2008, latest 2021), across 2 product codes in 1 review panel.
How long does FDA take to clear Somatex Medical Technologies GmbH's 510(k)s?
The median time from FDA receipt to decision across Somatex Medical Technologies GmbH's cleared 510(k)s is 140 days. Since 2017: 90 days, versus 123 days for all cleared 510(k)s in the same product codes.
What devices does Somatex Medical Technologies GmbH make?
Its most frequent FDA product codes are NEU (Marker, Radiographic, Implantable, 6); KNW (Instrument, Biopsy, 1).
Has Somatex Medical Technologies GmbH had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Somatex Medical Technologies GmbH; the most recent began 2021-02-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Somatex Medical Technologies GmbH clearances with predicates and recalls
- Run predicate analysis for product code NEU, Somatex Medical Technologies 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.