Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prometex, 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) |
|---|---|---|---|---|---|
| K894484 | AUDIOTESTER SCREENING AUDIOMETER | Prometex, Inc. | 1990-06-26 | 343 | 0 |
| K900068 | ARISTEE (RESIN, CROWN AND BRIDGES) | Prometex, Inc. | 1990-04-03 | 89 | 0 |
| K892710 | ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) | Prometex, Inc. | 1989-10-24 | 193 | 0 |
| K872894 | A2J MZ 44 LASER LIGHT FOR POSITIONING | Prometex, Inc. | 1987-08-12 | 20 | 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