# LXV: Apparatus, Vestibular Analysis

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- 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)
- 1998: 1
- 2007: 2
- 2008: 2
- 2009: 1
- 2010: 1
- 2012: 1
- 2018: 1
- 2019: 2
- 2020: 2
- 2022: 1

## Most-cited predicates
- K121590: Vestibular Analysis Apparatus (2012), cited by 3
- K070085: Balance Rehabilitation Unit (Bru) (2007), cited by 3
- K922037: System 2000, Rotational Vestibular Chair (1992), cited by 3
- K071973: Epley Omniax (2008), cited by 3
- K070676: Korebalance (Kinesthetic Ability Trainer) (2007), cited by 2
- K891008: Vestibular Ocular Reflex Test Equipment (Vorteq) (1989), cited by 2
- K911795: Kinesthetic Ability Trainer (K.a.T., Model 1000) (1991), cited by 1
- K851744: Equitest (1985), cited by 1

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