Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Infusion, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
259 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | 2008-02-19 | 259 | 0 |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | 2006-10-18 | 127 | 0 |
| K061356 | POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND | Advanced Infusion, Inc. | 2006-07-03 | 49 | 0 |
| K042246 | MULTI-DRIP INFUSION CATHETER | Advanced Infusion, Inc. | 2004-08-31 | 12 | 0 |
| K021964 | ALPHA INFUSION PUMP AND CATHETERS | Advanced Infusion, Inc. | 2002-08-12 | 59 | 0 |
| K992551 | ALPHA INFUSION PUMP | Advanced Infusion, Inc. | 1999-10-27 | 89 | 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