# JIW: Calibrator, Surrogate

- Device class: 2; regulation: 21 CFR 862.1150; FDA's rule: 510(k) exempt
- FDA decisions: 17
- 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)
- 1979: 1
- 1980: 2
- 1981: 1
- 1985: 3
- 1988: 4
- 1989: 1
- 1990: 2
- 1991: 1
- 1997: 2

## Most-cited predicates
- K970396: Human Chorionic Gonadotropin Calibrator (1997), cited by 1

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