Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicalex — 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) |
|---|---|---|---|---|---|
| K850946 | SURGICAL ASPIRATOR | Medicalex | 1985-09-16 | 193 | 0 |
| K851349 | LERE NAIL & PLATE COMBIN. ONE PIECE FORGED | Medicalex | 1985-05-29 | 55 | 0 |
| K833377 | MEDICALEX | Medicalex | 1984-09-27 | 364 | 0 |
| K831728 | MEDICALEX | Medicalex | 1984-01-09 | 223 | 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