# HQC: Unit, Phacofragmentation

- Device class: 2; regulation: 21 CFR 886.4670; FDA's rule: 510(k) required
- FDA decisions: 317
- 510(k) review time 2021–2025: median 229 days (middle half 163–267)
- Recalls: 42 (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: 1
- 2017: 3
- 2019: 4
- 2020: 4
- 2021: 1
- 2022: 4
- 2023: 1
- 2024: 5
- 2025: 3
- 2026: 3

## Most-cited predicates
- K911808: Gemini Ophthalmic Surgery System (1991), cited by 14
- K961310: Storz  Premiere II Microsurgical System (CX Series) (1996), cited by 11
- K021566: Infiniti (2002), cited by 10
- K063583: Alcon Vision System (2008), cited by 7
- K952213: Alcon Series 20000 Legacy Phacoemulsifier (1995), cited by 6
- K060366: The Amo Ophthalmic Surgical System (2006), cited by 6
- K101285: Constellation Vision System (2010), cited by 5
- K091777: Alcon Ultrachopper (2009), cited by 5
- K082845: Infiniti Vision System with Ozil IP (2009), cited by 5
- K955901: Storz DP4310DELUXE Phaco Pack Without Reflux (1996), cited by 4

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