Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KANEKA Corporation — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
235 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2018-03-19 | 235 | 0 |
| K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2017-07-07 | 99 | 0 |
| K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | 2017-04-07 | 127 | 0 |
| K163479 | R2P Metacross RX | KANEKA Corporation | 2017-01-11 | 30 | 0 |
| K160004 | Crosstella OTW | KANEKA Corporation | 2016-04-29 | 116 | 0 |
| K160013 | Crosperio OTW | KANEKA Corporation | 2016-04-29 | 116 | 0 |
| K152887 | Crosperio RX PTA Balloon Dilatation Catheter | KANEKA Corporation | 2016-01-22 | 114 | 0 |
| K152873 | Crosstella RX Balloon Dilatation Catheter | KANEKA Corporation | 2016-01-22 | 114 | 0 |
| K152080 | Metacross OTW PTA Balloon Dilatation Catheter | KANEKA Corporation | 2015-09-24 | 59 | 0 |
| K150865 | Metacross RX PTA Balloon Dilitation Catheter | KANEKA Corporation | 2015-08-03 | 124 | 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