Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
238 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012202 | NUMARIS 4VA15A | Siemens Medical Corp. | 2001-09-27 | 76 | 0 |
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM | Siemens Medical Corp. | 2001-03-30 | 18 | 24 |
| K994231 | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) | Siemens Medical Corp. | 2000-08-10 | 238 | 0 |
| K994316 | MAGNETOM OPEN VIVA WITH PERMANENT MAGNET | Siemens Medical Corp. | 2000-01-14 | 23 | 0 |
| K984634 | 3D-ANGIO | Siemens Medical Corp. | 1999-03-12 | 72 | 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