Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A & E Medical Corporation · 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) |
|---|---|---|---|---|---|
| K193479 | Sternal Cable System | A & E Medical Corporation | 2020-03-23 | 98 | 0 |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | 2018-10-12 | 115 | 0 |
| K180582 | Sternal Cable System | A & E Medical Corporation | 2018-05-31 | 87 | 0 |
| K173579 | Thorecon™ Fixation System | A & E Medical Corporation | 2018-02-12 | 84 | 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