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

Siemens Healthcare Diagnostics Products GmbH · Predicate Candidate Screening

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

114 daysmedian FDA review time
621 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPSiemens Healthcare Diagnostics Products GmbH2024-10-102510
K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH2023-12-13280
K220728vWF AgSiemens Healthcare Diagnostics Products GmbH2023-06-024450
K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH2022-12-164900
DEN200067INNOVANCE VWF AcSiemens Healthcare Diagnostics Products GmbH2022-09-297010
K212379N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2022-03-022120
K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2021-10-295110
K193047N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2021-07-146210
K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2019-05-03290
K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH2018-11-01900
K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbH2018-09-07880
K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC StaSiemens Healthcare Diagnostics Products GmbH2017-11-171580
K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH2017-10-31900
K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH2017-05-12320
K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH2016-12-26900
K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH2016-12-121040
K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH2016-09-021140
K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH2016-09-011140
K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH2016-01-262590

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