# Cardio Tek, BV

- Location (FDA's records): Ballwin, MO
- FDA decisions: 2 (2014–2016): 2 510(k) clearances
- Product codes: DQK (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mennen Medical, Inc.: 1 (https://510kreport.com/company/mennen-medical)

## Firms that cite its devices most
- Schwarzer Cardiotek GmbH: 1 (https://510kreport.com/company/schwarzer-cardiotek)

## Its most-cited devices
- K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System (2014), cited by 1
- K161245: EP-TRACER System (2016), cited by 1

## Recent decisions
- K161245: EP-TRACER System (Aug 5, 2016)
- K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System (Mar 31, 2014)

Source page: https://510kreport.com/company/cardio-tek