# HKP: Instrument, Vitreous Aspiration And Cutting, Battery-Powered

- Device class: 2; regulation: 21 CFR 886.4150; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1978: 1
- 1979: 3
- 1980: 1
- 1981: 2
- 1982: 1
- 1983: 1
- 1989: 1
- 1990: 1
- 1995: 2
- 1997: 1

## Most-cited predicates
- K950287: Univit Probe (1995), cited by 1
- K896622: Visitec Vitrectomy Unit (1990), cited by 1

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