Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acula Technology Corp. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241499 | 21.3” 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp. | 2024-06-13 | 16 | 0 |
| K233336 | 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp. | 2024-05-21 | 235 | 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