Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Computer Design & Applications, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843558 | DELTANODE, MEGA DELTA, DELTA LINK- | Computer Design & Applications, Inc. | 1984-11-13 | 64 | 0 |
| K841964 | MICRO DELTA & CELTAPRO | Computer Design & Applications, Inc. | 1984-08-21 | 99 | 0 |
| K837213 | MULTI-USER IMAGING AND ACQUISITION TERMINALS | Computer Design & Applications, Inc. | 1983-04-04 | 61 | 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