Atlas FDA

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

Medical Intelligence Medizintechnik GmbH · Predicate Candidate Screening

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

86 daysmedian FDA review time
113 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K143485iGuide 2.1Medical Intelligence Medizintechnik GmbH2015-03-04860
K121530BODYFIX SYSTEMMedical Intelligence Medizintechnik GmbH2012-06-20270
K112210FRAXIONMedical Intelligence Medizintechnik GmbH2011-11-221130
K072898HEXAPOD EVO RT COUCH TOPMedical Intelligence Medizintechnik GmbH2007-10-25141
K071870HEXAPOD RT COUCH TOPMedical Intelligence Medizintechnik GmbH2007-07-0820
K041448HEXAPOD RT COUCHTOPMedical Intelligence Medizintechnik GmbH2004-06-16150
K030439HEADFIXMedical Intelligence Medizintechnik GmbH2003-05-08861
K013391BODYFIXMedical Intelligence Medizintechnik GmbH2002-01-11880

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