# GWJ: Stimulator, Auditory, Evoked Response

- Device class: 2; regulation: 21 CFR 882.1900; FDA's rule: 510(k) required
- FDA decisions: 76
- 510(k) review time 2021–2025: median 147 days (middle half 108–183)
- 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)
- 2011: 2
- 2012: 1
- 2013: 2
- 2014: 2
- 2015: 1
- 2017: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2024: 2

## Most-cited predicates
- K013977: Echo-Screen T, TA, TD, Tda, TC (2002), cited by 6
- K103760: TITAN (2011), cited by 4
- K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. (1999), cited by 4
- K070608: Smartep, Model M010000 (2007), cited by 3
- K021895: Bio-Logic Master Evoked Response System (2002), cited by 3
- K936039: Algo-2 Newborn Hearing Screener (1995), cited by 3
- K013137: Algo 3 Newborn Hearing Screener (2001), cited by 3
- K092373: Ics Chartr EP 200 (2009), cited by 2
- K925648: Smart-Screener (Auditory) (1993), cited by 2
- K031051: Smartep-Assr, Model M811007 (2004), cited by 2

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