# QYX: Outpatient Cardiac Telemetry

- Device class: 2; regulation: 21 CFR 870.1025; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 268 days (middle half 243–328)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 1
- 2010: 1
- 2011: 2
- 2012: 1
- 2014: 2
- 2016: 1
- 2017: 3
- 2024: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 (2007), cited by 8
- K133701: Nuvant MCT System (2014), cited by 4
- K163512: Zio AT ECG Monitoring System (2017), cited by 4
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection (2010), cited by 3
- K063222: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 (2006), cited by 3
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), cited by 3
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), cited by 2
- K160064: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (2016), cited by 2
- K052240: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 (2005), cited by 2
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), cited by 2

Source page: https://510kreport.com/product-code/QYX
Data by year (CSV): https://510kreport.com/product-code/QYX.csv