Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Healthineers AG · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
206 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAG | Siemens Healthineers AG | 2026-07-31 | 137 | 0 |
| K253690 | LungMaps | Siemens Healthineers AG | 2026-06-15 | 206 | 0 |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | 2026-01-15 | 118 | 0 |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | 2025-11-20 | 23 | 0 |
| K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | 2025-10-24 | 203 | 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