# HQX: Implant, Orbital, Extra-Ocular

- Device class: 2; regulation: 21 CFR 886.3340; FDA's rule: 510(k) required
- FDA decisions: 16
- Recalls: 13 (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)
- 1980: 1
- 1983: 1
- 1987: 1
- 1990: 6
- 1995: 2
- 1996: 2
- 1998: 2
- 2003: 1

## Most-cited predicates
- K950806: Solid Dilicone Implants, Sdilicone Sponge Implants (1996), cited by 2
- K950599: Stors Scleral Sponge II (Lincoff Design) (1995), cited by 1
- K832481: Scleral Buckling Implants Dif/Types (1983), cited by 1

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