# KLW: Masker, Tinnitus

- Device class: 2; regulation: 21 CFR 874.3400; FDA's rule: 510(k) required
- FDA decisions: 78
- 510(k) review time 2021–2025: median 232 days (middle half 187–267)
- 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)
- 2013: 4
- 2014: 4
- 2015: 4
- 2016: 3
- 2017: 2
- 2018: 2
- 2020: 2
- 2023: 3
- 2024: 1
- 2026: 2

## Most-cited predicates
- K110932: Tinnitus Sound Generator Module (2011), cited by 7
- K030791: Anmp (Acoustic Neuro Modulation Protocol) (2003), cited by 6
- K974501: Digital Tinnitus Masking System (1998), cited by 6
- K111293: Soundcure Serenade Tinnitus Treatment System (2011), cited by 5
- K073636: Tinnitus Sound Generator Module (2008), cited by 4
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker (1996), cited by 4
- K963838: Starkey TM Air Conduction Tinnitus Masker (1996), cited by 4
- K003559: Tci (Tinnitus Control Instrument) (2001), cited by 3
- K791790: Model TM5 Behind Ear Tinnitus Masker (1979), cited by 3
- K982451: Ttcghi-T and TTCTN3-T-T (1999), cited by 2

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