Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Swiss Ray Medical Systems — 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) |
|---|---|---|---|---|---|
| K922813 | GEN-X 800-400 -- MODIFICATION | Swiss Ray Medical Systems | 1992-08-11 | 81 | 0 |
| K921539 | GEN-X 800/6/50 | Swiss Ray Medical Systems | 1992-08-11 | 132 | 0 |
| K915227 | GEN-X 800/500 | Swiss Ray Medical Systems | 1992-01-09 | 50 | 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