# GWL: Amplifier, Physiological Signal

- Device class: 2; regulation: 21 CFR 882.1835; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 178 days (middle half 106–190)
- Recalls: 2 (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)
- 2014: 1
- 2015: 1
- 2017: 2
- 2018: 1
- 2020: 1
- 2021: 2
- 2022: 1
- 2023: 2
- 2024: 4
- 2025: 1

## Most-cited predicates
- K003154: Mizar, Basis BE, Sandman Digital (2001), cited by 5
- K040113: Sandman SD20 Amplifier (2004), cited by 4
- K103140: Nicolet Wireless Eeg (2011), cited by 4
- K090957: Blackrock Neuroport Biopotential Signal Processing System (2009), cited by 3
- K053606: BE Plus / Aura-LTM64 Amplifier (2006), cited by 3
- K060803: G.Usbamp (2006), cited by 3
- K861014: Amplaid MK15 (Evoked Potential System) (1986), cited by 2
- K092699: Nomad Sleep System Recorder, Model PMU800 (2010), cited by 2
- K121996: BE Plus LTM Amplifier Gwi Amplifier (2012), cited by 2
- K172312: eego amplifiers (2018), cited by 2

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