Atlas FDA

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

Siemens Medical Solutions Diagnostics · Predicate Candidate Screening

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

141 daysmedian FDA review time
405 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100910IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6Siemens Medical Solutions Diagnostics2011-05-114050
K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6Siemens Medical Solutions Diagnostics2009-10-281180
K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATSiemens Medical Solutions Diagnostics2009-01-081892
K071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORSiemens Medical Solutions Diagnostics2008-09-114751
K073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions Diagnostics2008-06-271935
K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSiemens Medical Solutions Diagnostics2008-04-011940
K072794IMMULITE 2500 OM-MA, MODEL L5KOPSiemens Medical Solutions Diagnostics2007-11-05350
K071466DCA VANTAGE, MODEL 5075Siemens Medical Solutions Diagnostics2007-10-091330
K072204ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORSSiemens Medical Solutions Diagnostics2007-10-05580
K070727ADVIA CHEMISTRY ENZYMATIC CREATININE_2Siemens Medical Solutions Diagnostics2007-08-031414
K071017IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5Siemens Medical Solutions Diagnostics2007-05-02220

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