# Kaneka Medical America, LLC

- Location (FDA's records): New York, NY
- FDA decisions: 2 (2021–2021): 2 510(k) clearances
- Product codes: HCG (1), QEZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 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
- Kaneka Pharma America, LLC: 2 (https://510kreport.com/company/kaneka-pharma-america)

## Recent decisions
- K213166: Thrombuster II Aspiration Catheter (Oct 26, 2021)
- K210638: i-ED COIL System (Mar 26, 2021)

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