Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eigen Video — 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) |
|---|---|---|---|---|---|
| K935026 | DIGITAL MEDIA CONVERTER (D-MC) | Eigen Video | 1994-08-24 | 308 | 0 |
| K942264 | DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) | Eigen Video | 1994-07-20 | 72 | 0 |
| K850080 | DIGITAL IMAGE PROCESSOR FP-2C | Eigen Video | 1985-04-19 | 99 | 0 |
| K844375 | EIGEN FLORO-STOR FS-100 | Eigen Video | 1985-03-26 | 133 | 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