Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mckinley, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
249 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042228 | BEELINE MOTIV, PROPOLIS, PCA | Mckinley, Inc. | 2004-11-08 | 83 | 0 |
| K033039 | MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDU | Mckinley, Inc. | 2003-10-07 | 8 | 0 |
| K032642 | BEELINE SYSTEM | Mckinley, Inc. | 2003-09-23 | 27 | 0 |
| K991275 | WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED P | Mckinley, Inc. | 1999-07-01 | 78 | 0 |
| K990461 | MCKINLEY SP DISPOSABLE INFUSION PUMP | Mckinley, Inc. | 1999-06-30 | 138 | 0 |
| K982256 | OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PU | Mckinley, Inc. | 1998-09-30 | 96 | 0 |
| K971844 | MCKINLEY OUTBOUND-2 SYSTEM | Mckinley, Inc. | 1998-01-23 | 249 | 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