Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Somatex Medical Technologies GmbH · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

140 daysmedian FDA review time
273 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark ProfessSomatex Medical Technologies GmbH2021-02-182270
K182082Tumark for Eviva, Tumark for BreveraSomatex Medical Technologies GmbH2018-10-31900
K180443Tumark VisionSomatex Medical Technologies GmbH2018-03-22300
K111692TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATECSomatex Medical Technologies GmbH2011-11-081450
K102771BIOPSY HANDY, MRI BIOPSY HANDYSomatex Medical Technologies GmbH2011-06-242730
K093064TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MSomatex Medical Technologies GmbH2010-02-171400
K073095TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, Somatex Medical Technologies GmbH2008-03-191390

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda