# MIX: System, Vocal Cord Medialization

- Device class: 2; regulation: 21 CFR 874.3620; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 30 days (middle half 30–30)
- Recalls: 1 (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)
- 2001: 1
- 2003: 1
- 2006: 1
- 2007: 1
- 2008: 2
- 2009: 3
- 2013: 1
- 2015: 1
- 2018: 1
- 2024: 1

## Most-cited predicates
- K070090: Radiesse Laryngeal Implant (2007), cited by 4
- K080956: Modification to VF Gel Plus (2008), cited by 3
- K071663: VF Gel Plus (2008), cited by 3
- K033398: Laryngeal Augmentation Implant (2003), cited by 2
- K972317: Montgomery Thyroplasty Implant System (1997), cited by 2
- K180631: Silk Voice (2018), cited by 1
- K983525: Gore Revox Thyroplasty Implant (1998), cited by 1
- K060815: Juliesse Injectable Laryngeal Augmentation Implant (2006), cited by 1

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