Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Omni-Tract Surgical, Div. Minn. Scientific, 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) |
|---|---|---|---|---|---|
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 | 20 | 0 |
| K992583 | MASS (MICRO-ACCESS SPINE SYSTEM) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 1999-10-29 | 88 | 0 |
| K950214 | ABDOMINAL WALL RETRACTOR | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 1995-02-06 | 18 | 0 |
| K913803 | INTRALUMINAL ARTERY STRIPPER | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 1992-04-24 | 242 | 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