# MUI: Media, Coupling, Ultrasound

- Device class: 2; regulation: 21 CFR 892.1570; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 57 days (middle half 54–85)
- 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)
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 5
- 2019: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2026: 2

## Most-cited predicates
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels (2018), cited by 4
- K151070: Sonishield 100 Antimicrobial Ultrasound Gel (2016), cited by 4
- K112827: Sheathes Ultrasond Gel (2012), cited by 3
- K072515: Embrace Gel (2007), cited by 2
- K031894: Scantec Pad (2003), cited by 2
- K042619: Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant (2004), cited by 2
- K033178: Ultrabio (2004), cited by 1
- K131905: Solid Gel Pad (2013), cited by 1
- K083358: Lubricano-Ultrasound (2009), cited by 1
- K121311: Thixo-Gel Ultrasound Spray (2012), cited by 1

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