# GWK: Conditioner, Signal, Physiological

- Device class: 2; regulation: 21 CFR 882.1845; FDA's rule: 510(k) required
- FDA decisions: 23
- 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)
- 1984: 2
- 1985: 1
- 1986: 1
- 1987: 2
- 1988: 1
- 1990: 1
- 1991: 2
- 1999: 1
- 2005: 1
- 2006: 2

## Most-cited predicates
- K052489: Actiheart (2005), cited by 6
- K843598: Brain Function Mapping Option for Pathf (1985), cited by 3
- K801604: Pathfinder Electrodiagnostic System (1980), cited by 2
- K991045: Mini-Logger Series 2000 (1999), cited by 2
- K060919: Actical (2006), cited by 1

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