Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kaneka Pharma America, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | 2020-04-25 | 268 | 0 |
| K170247 | Lacriflow CL | Kaneka Pharma America, LLC | 2017-04-18 | 81 | 0 |
| K121301 | XPRESSWAY RX CATHETER (6F LD-VERISON) | Kaneka Pharma America, LLC | 2012-07-30 | 90 | 0 |
| K101839 | KANEKA PHARMA AMERICA XPRESS-WAY RX | Kaneka Pharma America, LLC | 2010-10-22 | 113 | 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