# Pentax Medical of America, Inc.

- Location (FDA's records): Montvale, NJ
- FDA decisions: 2 (2018–2018): 2 510(k) clearances
- Product codes: FDS (1), FDF (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
- Pentax Medical Company: 2 (https://510kreport.com/company/pentax-medical)

## Recent decisions
- K180285: PENTAX Medical Video Colonoscope EC34-i10T Series (Oct 26, 2018)
- K180292: PENTAX Video Upper G.I. Scope EG34-i10 (Oct 12, 2018)

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