# HQD: Lens, Contact (Other Material) - Daily

- Device class: 2; regulation: 21 CFR 886.5916; FDA's rule: 510(k) required
- FDA decisions: 120
- 510(k) review time 2021–2025: median 79 days (middle half 57–156)
- Recalls: 1 (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)
- 2016: 7
- 2017: 9
- 2018: 5
- 2019: 2
- 2020: 1
- 2021: 3
- 2022: 3
- 2023: 3
- 2024: 5
- 2026: 1

## Most-cited predicates
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses (2006), cited by 8
- K000795: Rigid Gas Permeable Contact Lens (2000), cited by 7
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens (2007), cited by 6
- K943177: Boston (R) 7 - 30(Enflufocon a) (1994), cited by 6
- K161461: BostonSight PD Prosthetic Device (2016), cited by 5
- K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses (2007), cited by 5
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses (2004), cited by 5
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (2017), cited by 5
- K201194: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2020), cited by 4
- K940277: Paflufocon a, B, C & D (1994), cited by 4

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