Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Umi, 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) |
|---|---|---|---|---|---|
| K883527 | GRID/RADIOGRAPHIC | Umi, Inc. | 1988-09-02 | 15 | 0 |
| K831412 | CRM-100 COLOR VIDEO CAMERA | Umi, Inc. | 1983-06-03 | 32 | 0 |
| K830924 | CRM-114 COLOR VIDEO CAMERA | Umi, Inc. | 1983-04-18 | 27 | 0 |
| K823382 | NEPHROSTOMY CATHETER | Umi, Inc. | 1983-01-28 | 77 | 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