# Cardiac Designs, LLC

- Location (FDA's records): Monroe, CT
- FDA decisions: 3 (2013–2017): 3 510(k) clearances
- Names in FDA's records: Cardiac Designs, LLC (2); Cardiac Designs, Inc. (1)
- Product codes: DXH (2), DQK (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (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
- Card Guard Scientific Survival, Ltd.: 1 (https://510kreport.com/company/card-guard-scientific-survival)

## Firms that cite its devices most
- AliveCor, Inc.: 1 (https://510kreport.com/company/alivecor)

## Its most-cited devices
- K122184: Ecg Check (2013), cited by 2

## Recent decisions
- K170506: ECG Check - Universal, ECG Check - Universal Plus (Oct 2, 2017)
- K131045: Enterprise Ecg Analysis / Interpretation Software (May 29, 2013)
- K122184: Ecg Check (Feb 14, 2013)

Source page: https://510kreport.com/company/cardiac-designs