Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infusaid Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
303 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910448 | SNAP-LOCK MICRO PORT, MODIFICATION | Infusaid Corp. | 1991-11-21 | 303 | 0 |
| K901419 | DUAL PORT | Infusaid Corp. | 1990-09-05 | 163 | 0 |
| K902251 | SUBCLAVIAN INTRODUCER SET | Infusaid Corp. | 1990-07-31 | 76 | 0 |
| K860898 | SUBCLAVIAN INTRODUCER SET | Infusaid Corp. | 1986-04-29 | 50 | 0 |
| K840481 | INFUSE-A-PORT HEPARIN LOCK MAINT KIT | Infusaid Corp. | 1984-09-18 | 225 | 0 |
| K842355 | INFUSAID INFUSE-A-PORT | Infusaid Corp. | 1984-08-06 | 46 | 0 |
| K832788 | INFUSE-A-PORT | Infusaid Corp. | 1983-09-15 | 27 | 0 |
| K823838 | INFUSE-A-PORT | Infusaid Corp. | 1983-01-12 | 15 | 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