# MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

- Device class: 2; regulation: 21 CFR 870.2800; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 249 days (middle half 240–257)
- 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)
- 2010: 1
- 2011: 3
- 2012: 1
- 2013: 2
- 2014: 1
- 2018: 1
- 2020: 2
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K010949: 2010 Plus Holter for Windows (2001), cited by 5
- K990170: Holter 2000 (1999), cited by 4
- K042108: Vista Plus (2005), cited by 4
- K031466: Iqmark Digital Holter (2003), cited by 3
- K043454: Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410 (2005), cited by 2
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (2012), cited by 2
- K010396: C. NET 2100 (2001), cited by 1
- K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor) (2011), cited by 1
- K051730: Matrix Holter System, Model M12 (2005), cited by 1
- K004017: H-Scribe (2001), cited by 1

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