Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flowmedica, 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) |
|---|---|---|---|---|---|
| K082163 | FLOWMEDICA BENEPHIT INFUSION SYSTEMS | Flowmedica, Inc. | 2008-10-29 | 90 | 6 |
| K050205 | BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SH | Flowmedica, Inc. | 2005-03-04 | 35 | 2 |
| K033569 | FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND | Flowmedica, Inc. | 2004-01-13 | 62 | 2 |
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