# Kaneka Americas Holding, Inc.

- Location (FDA's records): Newark, CA
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: QJP (1)
- Predicates its devices cite: 1 (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
- Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular: 1 (https://510kreport.com/company/micro-therapeutics-lnc-d-b-a-ev3-neurovascular)

## Recent decisions
- K251668: SurfRider 13 Microcatheter (Jan 5, 2026)

Source page: https://510kreport.com/company/kaneka-americas-holding