# Kaneka Pharma America, LLC

- Location (FDA's records): New York, NY
- FDA decisions: 5 (1996–2020): 4 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Kaneka Pharma America, LLC (4); Kaneka Pharma America Corp. (1)
- Product codes: QEZ (2), MMY (1), OKS (1), HCG (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Neurovascular: 2 (https://510kreport.com/company/stryker-neurovascular)
- Hiroyasu Higuchi: 1 (https://510kreport.com/company/hiroyasu-higuchi)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)
- Blockade Medical: 1 (https://510kreport.com/company/blockade-medical)

## Firms that cite its devices most
- Kaneka Medical America, LLC: 2 (https://510kreport.com/company/kaneka-medical-america)
- Control Medical Technology: 1 (https://510kreport.com/company/control-medical-technology)

## Its most-cited devices
- K101839: Kaneka Pharma America Xpress-Way RX (2010), cited by 1
- K192068: i-ED COIL (2020), cited by 1
- K121301: Xpressway RX Catheter (6F LD-Verison) (2012), cited by 1

## Recent decisions
- K192068: i-ED COIL (Apr 25, 2020)
- K170247: Lacriflow CL (Apr 18, 2017)
- K121301: Xpressway RX Catheter (6F LD-Verison) (Jul 30, 2012)
- K101839: Kaneka Pharma America Xpress-Way RX (Oct 22, 2010)
- P910018: Liposorber (R) LA-15 System Adsorption Column, Sulfux (R) FS-05 Plasma Separator, and Tub. Syst. for Plasmapher. (LT-MA2). (Feb 21, 1996)

Source page: https://510kreport.com/company/kaneka-pharma-america