Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cyberex Corp. — 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) |
|---|---|---|---|---|---|
| K810837 | CYBER 80 HEMODIALYZER | Cyberex Corp. | 1981-05-05 | 40 | 0 |
| K802478 | CYBER 120 HEMODIALYZER | Cyberex Corp. | 1981-03-20 | 169 | 0 |
| K801377 | CYBER 120 HEMODIALYZER | Cyberex Corp. | 1980-08-27 | 77 | 0 |
| K790824 | REPGREEN ULTRAFILTRATION MONITOR | Cyberex Corp. | 1979-06-27 | 57 | 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