Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mcpherson Enterprises, 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) |
|---|---|---|---|---|---|
| K061484 | MODIFICATION TO: SMITHWICK CAROTID SHUNT | Mcpherson Enterprises, Inc. | 2006-12-07 | 191 | 0 |
| K062474 | SMITHWICK CAROTID SHUNT | Mcpherson Enterprises, Inc. | 2006-11-09 | 77 | 0 |
| K823565 | MULTI-LUMEN INTRAVENOUS CATHETER | Mcpherson Enterprises, Inc. | 1982-12-16 | 13 | 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