# MVA: Orthosis, Cranial

- Device class: 2; regulation: 21 CFR 882.5970; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 204 days (middle half 167–363)
- Recalls: 0 (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)
- 2006: 1
- 2007: 2
- 2010: 1
- 2011: 3
- 2014: 3
- 2018: 1
- 2021: 2
- 2022: 3
- 2023: 2
- 2024: 1

## Most-cited predicates
- DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band (1998), cited by 9
- K001167: Opi Band (2000), cited by 5
- K003035: Clarren Helmet (2001), cited by 4
- K003630: Danmar Products Michigan Cranial Helmet (2001), cited by 2
- K140353: Starband and Starlight (2014), cited by 2
- K013700: Orthosis Helmet Molding (2002), cited by 1
- K230444: Talee, Talee PostOp (2023), cited by 1
- K030669: Providence Molding Helmet (2003), cited by 1
- K223238: STARband 3D (2023), cited by 1
- K111609: Boston Band (2011), cited by 1

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