Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Healthcare Diagnostics Products, Ltd. · 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) |
|---|---|---|---|---|---|
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 | 90 | 0 |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 | 675 | 0 |
| K202826 | IMMULITE® 2000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 | 113 | 0 |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 | 71 | 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