# MWJ: Electrocardiograph, Ambulatory (Without Analysis)

- Device class: 2; regulation: 21 CFR 870.2800; FDA's rule: 510(k) required
- FDA decisions: 64
- 510(k) review time 2021–2025: median 230 days (middle half 166–457)
- Recalls: 2 (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)
- 2011: 3
- 2012: 1
- 2013: 3
- 2014: 2
- 2016: 2
- 2018: 1
- 2021: 1
- 2022: 4
- 2024: 2
- 2026: 5

## Most-cited predicates
- K993617: Digitrakplus Holter Recorder (1999), cited by 7
- K993618: DXP1000 Holter Recorder (1999), cited by 6
- K050731: Seer Light Extend Compact Digital Holter System (2005), cited by 4
- K032466: Spiderview (2003), cited by 4
- K021373: H12+Holter Recorder (2002), cited by 4
- K001288: DR180-II (2000), cited by 3
- K003707: Cardionet Ambulatory Ecg Monitor, Model CN1000A (2001), cited by 3
- K021470: Seer Light Compact Digital Holter Recorder (2002), cited by 3
- K073545: Audicor, Hemo Ambulatory Monitor (2008), cited by 3
- K043010: Holter Recorder H3+ (2005), cited by 2

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