# DPS: Electrocardiograph

- Device class: 2; regulation: 21 CFR 870.2340; FDA's rule: 510(k) required
- FDA decisions: 580
- 510(k) review time 2021–2025: median 233 days (middle half 157–263)
- Recalls: 78 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 9
- 2018: 14
- 2019: 3
- 2020: 6
- 2021: 5
- 2022: 6
- 2023: 10
- 2024: 8
- 2025: 6
- 2026: 6

## Most-cited predicates
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801 (2006), cited by 11
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 (2007), cited by 9
- K082946: Mortara Eli 350 Electrocardiograph (2008), cited by 7
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), cited by 7
- K941811: HP M1175A, M1176A, Component Monitoring System (1994), cited by 7
- K090483: Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series Patient Monitors (2009), cited by 6
- K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option (1999), cited by 6
- K020708: Philips Pagewriter Touch Cardiograph, Model M5000A Series (2002), cited by 6
- K212112: Cardiologs Holter Platform (2021), cited by 5
- K051534: Cardioline AR 600, AR 1200, AR 2100 (2005), cited by 5

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