Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Surgical Concepts, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870411 | CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA. | Medical Surgical Concepts, Inc. | 1987-06-02 | 119 | 0 |
| K870413 | PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) | Medical Surgical Concepts, Inc. | 1987-06-01 | 118 | 0 |
| K870412 | TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT | Medical Surgical Concepts, Inc. | 1987-05-27 | 113 | 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