# MXD: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

- Device class: 2; regulation: 21 CFR 870.1025; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 44 days (middle half 30–97)
- Recalls: 8 (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)
- 2016: 3
- 2017: 4
- 2019: 1
- 2020: 4
- 2021: 4
- 2022: 2
- 2023: 6
- 2024: 1
- 2025: 3
- 2026: 2

## Most-cited predicates
- K152995: BioMonitor 2-AF, BioMonitor 2-S (2016), cited by 3
- K200795: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (2020), cited by 3
- K132649: Reveal Linq Insertable Cardiac Monitor (2014), cited by 3
- K162855: Reveal LINQ (2017), cited by 2
- K233320: LINQ II™ Insertable Cardiac Monitor (LNQ22) (2023), cited by 2
- K150614: Reveal LINQ (2015), cited by 2
- K193473: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (2020), cited by 2
- K221962: LINQ II Insertable Cardiac Monitor (2022), cited by 1
- K160689: Reveal LINQ (2016), cited by 1
- K251221: Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (2025), cited by 1

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