# MUA: Bone Sonometer

- Device class: 2; regulation: 21 CFR 892.1180; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 270 days (middle half 224–315)
- 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)
- 2002: 2
- 2003: 2
- 2004: 2
- 2011: 2
- 2013: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K110646: Beammed Sunlight Miniomni Bone Sonometer (2011), cited by 2
- K161919: UltraScan 650 (2017), cited by 1
- P970040: Achilles Express Ultrasonometer (1998), cited by 1
- K180516: EchoS (2018), cited by 1
- K103633: Achilles (2011), cited by 1
- K152020: Bindex BI-100 (2016), cited by 1
- K202514: EchoS Family (2021), cited by 1
- K161971: Bindex BI-2 (2017), cited by 1
- P990035: The Sunlight Omnisense (TM) Ultrasound Bone Sonometer (2000), cited by 1

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