# OAN: Orthosis, Cranial, Laser Scan

- Device class: 2; regulation: 21 CFR 882.5970; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 91 days (middle half 64–128)
- 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)
- 2008: 5
- 2009: 2
- 2013: 1
- 2014: 1
- 2015: 3
- 2016: 1
- 2018: 1
- 2021: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K011350: Starband Cranial Orthosis (2001), cited by 7
- K082950: Starband (2008), cited by 4
- K072566: Hanger Cranial Band (2008), cited by 4
- K180109: STARband, STARlight, St. Louis Band (2018), cited by 3
- K151979: STARband, STARlight (2015), cited by 3
- K072862: Boston-Band Cranial Remodling Orthosis (2008), cited by 3
- K124023: Starband (2013), cited by 2
- K014012: Doc Band (2002), cited by 2
- K081994: Starlight (2008), cited by 2
- K161138: St. Louis Band (2016), cited by 1

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