# GYD: Transducer, Tremor

- Device class: 2; regulation: 21 CFR 882.1950; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 241 days (middle half 219–263)
- Recalls: 0 (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)
- 1979: 1
- 1997: 1
- 2001: 2
- 2007: 1
- 2014: 1
- 2016: 1
- 2022: 3
- 2023: 1
- 2025: 1
- 2026: 3

## Most-cited predicates
- K220820: Parky App (2022), cited by 3
- K140086: Personal Kinetigraph (PKG) System (2014), cited by 2
- K213519: Rune Labs Tremor Transducer System (2022), cited by 2
- K161717: Personal Kinetigraph (PKG) System (2016), cited by 2
- K250153: Neu Platform (2025), cited by 1
- K211887: Personal Kinetigraph (PKG) System Gen 2 Plus (2022), cited by 1
- K971318: MM-1 Movement Monitor (1997), cited by 1
- K063872: Kinesia (2007), cited by 1
- K010270: Tremorometer (2001), cited by 1

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