Atlas FDA

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

Medical Measurement Systems B.V. — Predicate Candidate Screening

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

117 daysmedian FDA review time
350 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121014SOLAR GIMedical Measurement Systems B.V.2012-08-011201
K071094MODIFICATION TO SOLAR GIMedical Measurement Systems B.V.2007-08-131170
K060166OHMEGAMedical Measurement Systems B.V.2006-04-21880
K052338SOLAR GIMedical Measurement Systems B.V.2005-12-151110
K050993MMS VIDEO OPTIONMedical Measurement Systems B.V.2005-05-26370
K031084SOLAR GI SYSTEMMedical Measurement Systems B.V.2004-03-193500
K031930HIGH SPEED EMG MODULEMedical Measurement Systems B.V.2004-03-032540

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