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

Roche Diagnostics GmbH — Predicate Candidate Screening

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

23 daysmedian FDA review time
266 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252431Elecsys CalcitoninRoche Diagnostics GmbH2026-04-242660
K143446Accu-Chek FlexLink Plus infusion setRoche Diagnostics GmbH2015-08-132540
K981282ELECSYS AFPRoche Diagnostics GmbH1998-05-01230
K981281ELECSYS CALCHECK FERRITINRoche Diagnostics GmbH1998-04-24160
K981278ELECSYS CALCHECK CA 125IIRoche Diagnostics GmbH1998-04-23150

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