Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Danam Electronics — 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) |
|---|---|---|---|---|---|
| K945678 | DATACELL 18MS | Danam Electronics | 1995-09-12 | 298 | 0 |
| K910283 | DANAM DATACELL-18 | Danam Electronics | 1991-04-12 | 79 | 0 |
| K892205 | DANAM VECTOR-8+ | Danam Electronics | 1989-06-13 | 71 | 0 |
| K840649 | DANAM ELEC. SA-1000 | Danam Electronics | 1984-07-19 | 155 | 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