# KANEKA Corporation

- Location (FDA's records): Tokyo, JP
- FDA decisions: 11 (2011–2018): 11 510(k) clearances
- Names in FDA's records: KANEKA Corporation (10); Kaneka Corp. (1)
- Product codes: LIT (6), LOX (3), DQY (1), OTZ (1)
- 510(k) review time since 2016: median 115 days, against 115 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 17 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ev3, Inc.: 4 (https://510kreport.com/company/ev3)
- Bard Peripheral Vascular, Inc.: 3 (https://510kreport.com/company/bard-peripheral-vascular)
- Scimed Life Systems, Inc.: 1 (https://510kreport.com/company/scimed-life-systems)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Ocular Systems, Inc.: 1 (https://510kreport.com/company/ocular-systems)

## Firms that cite its devices most
- Smartcardia SA: 1 (https://510kreport.com/company/smartcardia)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)

## Its most-cited devices
- K150865: Metacross RX PTA Balloon Dilitation Catheter (2015), cited by 3
- K152080: Metacross OTW PTA Balloon Dilatation Catheter (2015), cited by 1
- K152873: Crosstella RX Balloon Dilatation Catheter (2016), cited by 1
- K163372: RX Takeru Balloon Dilatation Catheter (2017), cited by 1
- K160004: Crosstella OTW (2016), cited by 1

## Recent decisions
- K172264: OTW Takeru PTCA Balloon Dilatation Catheter (Mar 19, 2018)
- K170941: RX NC Takeru PTCA Balloon Dilatation Catheter (Jul 7, 2017)
- K163372: RX Takeru Balloon Dilatation Catheter (Apr 7, 2017)
- K163479: R2P Metacross RX (Jan 11, 2017)
- K160013: Crosperio OTW (Apr 29, 2016)
- K160004: Crosstella OTW (Apr 29, 2016)
- K152873: Crosstella RX Balloon Dilatation Catheter (Jan 22, 2016)
- K152887: Crosperio RX PTA Balloon Dilatation Catheter (Jan 22, 2016)

Source page: https://510kreport.com/company/kaneka