Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Mondeal Medical Systems GmbH · Predicate Candidate Screening

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

77 daysmedian FDA review time
343 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K072740MONDEAL EXTREMITY BONE FIXATION SYSTEMMondeal Medical Systems GmbH2007-11-19530
K071797MONDEAL HAND CONTOUR SYSTEMMondeal Medical Systems GmbH2007-09-17770
K071798MONDEAL DISTAL RADIUS SYSTEMMondeal Medical Systems GmbH2007-09-17770
K062436SIS SINUS IMPLANT STABILIZERMondeal Medical Systems GmbH2007-07-303430
K050257LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)Mondeal Medical Systems GmbH2005-02-0740
K042345LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)Mondeal Medical Systems GmbH2005-01-131360

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