Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Healthcare Diagnostic Products GmbH · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 | 184 | 0 |
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 | 90 | 0 |
| K172286 | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Products GmbH | 2017-12-18 | 143 | 0 |
| K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostic Products GmbH | 2016-01-11 | 301 | 0 |
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