Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Minnesota Scientific, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
32 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872919 | OMNI-TRACT CORRAL RETRACTOR | Minnesota Scientific, Inc. | 1987-08-11 | 15 | 0 |
| K853948 | MINNESOTA SCIENTIFIC, INC. OMNI-BEAM | Minnesota Scientific, Inc. | 1985-10-16 | 22 | 0 |
| K853947 | OMNI-TRACT CHEST WALL & LUNA RETRACTOR | Minnesota Scientific, Inc. | 1985-10-16 | 22 | 0 |
| K842762 | OMNI-TRACT SURGICAL RETRACTOR SYS | Minnesota Scientific, Inc. | 1984-08-17 | 32 | 0 |
| K810282 | OPERATING TABLE ACCESSORY CLAMP | Minnesota Scientific, Inc. | 1981-02-26 | 24 | 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