# Prodeon Medical, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: QKA (2), FED (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Medi-Tate, Ltd.: 1 (https://510kreport.com/company/medi-tate)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)

## Its most-cited devices
- K253525: Urocross Expander System (Model Numbers ES2018 and ES3025) (2026), cited by 1

## Recent decisions
- K261342: Urocross Expander System (UES-2018-C1) (Jun 22, 2026)
- K253525: Urocross Expander System (Model Numbers ES2018 and ES3025) (Mar 12, 2026)
- K252572: Prodeon Urethral Sheath System (Oct 7, 2025)

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