Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medfusion, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
197 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905783 | MODIFIED WALKMED 400 | Medfusion, Inc. | 1991-01-11 | 24 | 0 |
| K905029 | MODEL 2001, MODIFICATION | Medfusion, Inc. | 1990-12-24 | 54 | 0 |
| K901755 | MODEL 3001 SYRINGE INFUSION PUMP | Medfusion, Inc. | 1990-08-29 | 134 | 0 |
| K890862 | AMBULATORY INFUSION PUMP | Medfusion, Inc. | 1989-08-03 | 163 | 0 |
| K890120 | SYRINGE INFUSION PUMP | Medfusion, Inc. | 1989-07-27 | 197 | 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