# EWL: Prosthesis, Laryngeal (Taub)

- Device class: 2; regulation: 21 CFR 874.3730; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 273 days (middle half 273–273)
- Recalls: 3 (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)
- 1998: 1
- 1999: 1
- 2002: 1
- 2004: 1
- 2008: 1
- 2009: 1
- 2010: 2
- 2013: 1
- 2014: 1
- 2024: 1

## Most-cited predicates
- K932120: Blom-Singer Indwelling Low Pressure Voice Prosthes (1994), cited by 3
- K971244: Provox 2 Voice Prosthesis System (1997), cited by 3
- K821568: Blow-Singer Tracheostoma Valve (1982), cited by 3
- K022125: Provox Freehands Hme, Model 7710 (2002), cited by 2
- K945287: Inhealth Blom-Singer Indwelling Valved Insert Accessory Device (1994), cited by 1
- K930105: Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. (1993), cited by 1
- K932163: Blom-Singer Voice Prosthesis Flushing Pipet (1993), cited by 1
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis (1999), cited by 1
- K945288: Inhealth Blom-Singer Indwelling Plug Insert Accessory Device (1994), cited by 1
- K131947: Provox Vega Puncture Set (2013), cited by 1

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