# DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

- Device class: 2; regulation: 21 CFR 870.2910; FDA's rule: 510(k) required
- FDA decisions: 192
- 510(k) review time 2021–2025: median 181 days (middle half 142–289)
- Recalls: 4 (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)
- 2017: 7
- 2018: 6
- 2019: 5
- 2020: 6
- 2021: 2
- 2022: 6
- 2023: 4
- 2024: 3
- 2025: 3
- 2026: 2

## Most-cited predicates
- K040966: Modification to Carematix Wellness System (2004), cited by 16
- K080798: Intel Health Guide, Model: PHS6000 (2008), cited by 10
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) (2002), cited by 10
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), cited by 9
- K051470: Remote Care Management Systems (RCMS) (2005), cited by 9
- K072698: Confidant 2.5 (2007), cited by 8
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), cited by 7
- K050567: Health Buddy Appliance (2005), cited by 7
- K974149: Ambulatory X-12 Telemetry Module (1998), cited by 7
- K063612: Modification to Health Buddy Appliance (2006), cited by 6

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