Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omnis Surgical, 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) |
|---|---|---|---|---|---|
| K854518 | EPIDURAL ANESTHESIA TRAY | Omnis Surgical, Inc. | 1985-12-23 | 41 | 0 |
| K850979 | HEMOCONCENTRATOR KIT | Omnis Surgical, Inc. | 1985-07-29 | 143 | 0 |
| K844993 | COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 | Omnis Surgical, Inc. | 1985-02-28 | 64 | 0 |
| K843595 | CARDIOTOMY RESERVOIR W/FILTER | Omnis Surgical, Inc. | 1985-02-14 | 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