Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
First Medical, Inc. · 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) |
|---|---|---|---|---|---|
| K014024 | MODIFICATION TO ALPHA DX SYSTEM | First Medical, Inc. | 2001-12-18 | 12 | 0 |
| K013118 | MODIFICATION TO ALPHA DX SYSTEM | First Medical, Inc. | 2001-10-15 | 27 | 0 |
| K010562 | ALPHA DX SYSTEM | First Medical, Inc. | 2001-03-13 | 15 | 0 |
| K974839 | ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC | First Medical, Inc. | 1998-02-04 | 42 | 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