Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Heatlhcare Diagnostics, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102772 | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, D | Siemens Heatlhcare Diagnostics, Inc. | 2011-10-07 | 378 | 0 |
| K102045 | DIMENSION VISA HBA1C, MODEL K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 | 208 | 3 |
| K100293 | ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 | Siemens Heatlhcare Diagnostics, Inc. | 2010-03-19 | 45 | 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