# HQE: Instrument, Vitreous Aspiration And Cutting, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.4150; FDA's rule: 510(k) required
- FDA decisions: 149
- 510(k) review time 2021–2025: median 344 days (middle half 344–344)
- Recalls: 23 (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)
- 1999: 3
- 2001: 1
- 2002: 1
- 2003: 3
- 2011: 1
- 2012: 2
- 2014: 1
- 2016: 1
- 2017: 1
- 2022: 1

## Most-cited predicates
- K894278: Storz Daisyplus Series Microsurgical Systems (1989), cited by 5
- K921758: Storz Protege Opthalmic Microsurgical System (1992), cited by 3
- K946135: Infinitech Aspirating Laser Probe (1995), cited by 3
- K932669: Supra-Vit (TM) (1994), cited by 3
- K953575: Storz MVS-3201 Vitrectomy Probe Pack (1995), cited by 3
- K141065: Constellation Vision System (2014), cited by 2
- K921460: Storz Premiere/Premiere Microvit Microsurg Systems (1992), cited by 2
- K102222: Ultimate Vit Enhamcer (Uve) (2011), cited by 2
- K961738: Vit Commander System (1996), cited by 2
- K885196: Laser Indirect Ophthalmoscope (Lio) (1989), cited by 2

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