# Cardiosense, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 2 (2025–2026): 1 510(k) clearance and 1 De Novo grant
- Product codes: DXR (1), SIF (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
- Heartforce Medical, Inc.: 1 (https://510kreport.com/company/heartforce-medical)
- Meridian AG: 1 (https://510kreport.com/company/meridian)

## Recent decisions
- DEN250057: PCWP Analysis Software (May 22, 2026)
- K243566: CardioTag™ (Jul 22, 2025)

Source page: https://510kreport.com/company/cardiosense