# Cardiac Insight, Inc.

- Location (FDA's records): Kirkland, WA
- FDA decisions: 3 (2013–2017): 3 510(k) clearances
- Product codes: DSH (3)
- Predicates its devices cite: 4 (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
- iRhythm Technologies, Inc.: 1 (https://510kreport.com/company/irhythm-technologies)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- AliveCor, Inc.: 1 (https://510kreport.com/company/alivecor)

## Its most-cited devices
- K130288: Stealth Monitor, Stealth Docking Cable, Stealth Display and Storage Device (2013), cited by 1

## Recent decisions
- K162503: Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software (Mar 24, 2017)
- K142468: Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System (Jul 11, 2015)
- K130288: Stealth Monitor, Stealth Docking Cable, Stealth Display and Storage Device (May 29, 2013)

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