Atlas FDA

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

Biomedical Diagnostics (Bmd) SA — Predicate Candidate Screening

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

148 daysmedian FDA review time
308 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISBiomedical Diagnostics (Bmd) SA2010-12-03840
K100917FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEMBiomedical Diagnostics (Bmd) SA2010-11-032150
K070458MODIFICATION TO FIDIS VASCULITIS, MODEL MX007Biomedical Diagnostics (Bmd) SA2007-12-213080
K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006Biomedical Diagnostics (Bmd) SA2007-12-192320
K061794FIDIS TM THYRO, MODEL MX002Biomedical Diagnostics (Bmd) SA2006-11-211480
K060380FIDIS DSDNABiomedical Diagnostics (Bmd) SA2006-05-02770
K053383FIDIS CELIACBiomedical Diagnostics (Bmd) SA2006-03-291140
K053653FIDIS CONNECTIVE 10, MODEL MX006Biomedical Diagnostics (Bmd) SA2006-03-13730
K053012FIDIS VASCULITIS, MODEL MX007Biomedical Diagnostics (Bmd) SA2006-03-021270
K050286FIDIS CONNECTIVE 8Biomedical Diagnostics (Bmd) SA2005-10-032380

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