# MXC: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

- Device class: 2; regulation: 21 CFR 870.2800; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 67 days (middle half 48–85)
- 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)
- 2008: 1
- 2009: 2
- 2010: 1
- 2012: 2
- 2014: 1
- 2017: 2
- 2019: 3
- 2020: 3
- 2021: 1
- 2023: 1

## Most-cited predicates
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator (2008), cited by 6
- K994331: Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator (2000), cited by 4
- K003667: Reveal Plus Insertable Loop Recorder (2001), cited by 3
- K163407: Confirm Rx Insertable Cardiac Monitor (ICM) System (2017), cited by 2
- K063035: Sleuth Implantable Ecg Monitoring System (2007), cited by 2
- K193310: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (2020), cited by 2
- K122161: SJM Confirm (2012), cited by 1
- K190295: Confirm Rx Insertable Cardiac Monitor (2019), cited by 1
- K083828: Sleuth at Implantable Cardiac Monitoring System -6 CM  and 8CM Antenna, Personal Diagnostics Manager (PDM) Accessory Kit (2009), cited by 1
- K122090: SJM Confirm Implantable Cardiac Monitor (2012), cited by 1

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