# DXH: Transmitters And Receivers, Electrocardiograph, Telephone

- Device class: 2; regulation: 21 CFR 870.2920; FDA's rule: 510(k) required
- FDA decisions: 297
- 510(k) review time 2021–2025: median 187 days (middle half 98–289)
- Recalls: 9 (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: 1
- 2017: 5
- 2018: 4
- 2019: 6
- 2020: 5
- 2021: 3
- 2022: 4
- 2023: 1
- 2025: 4
- 2026: 1

## Most-cited predicates
- K042254: PMP4 Selfcheck Ecg (2005), cited by 7
- K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) (1997), cited by 5
- K923930: Electrocardiograph Transmitter (1992), cited by 5
- K012223: CG-2211 Selfcheck Ecg Transmitter (2001), cited by 5
- K142743: AliveCor Heart Monitor (2015), cited by 5
- K071130: Heartrak AF (2008), cited by 4
- K010945: Heartcard, Model 5258 (2001), cited by 4
- K141813: Rhythmstar System (2014), cited by 4
- K052556: CG-7000DX-BT Ecg Recorder/Transmitter (2006), cited by 4
- K894277: M1400A Transmitter,M1402 Receiver,M1401 Mainframe (1989), cited by 3

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