Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A2j, 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) |
|---|---|---|---|---|---|
| K931974 | AZ 92 | A2j, Inc. | 1993-10-08 | 169 | 0 |
| K904127 | A2J TELEMETER | A2j, Inc. | 1991-01-04 | 128 | 0 |
| K881591 | A2J MZ 45 LASER LIGHT FOR POSITIONING | A2j, Inc. | 1988-04-27 | 14 | 0 |
| K880981 | A2J MZ 44 B TYPE | A2j, Inc. | 1988-04-22 | 45 | 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