# KRK: Manometer, Blood-Pressure, Venous

- Device class: 2; regulation: 21 CFR 870.1140; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1979: 1
- 1981: 1
- 1982: 1
- 1983: 1
- 1986: 1
- 1988: 1
- 1989: 1
- 1990: 1
- 1995: 1

## Most-cited predicates

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