# KSG: Media, Potentiating For In Vitro Diagnostic Use

- Device class: 2; regulation: 21 CFR 864.9600; FDA's rule: 510(k) exempt
- FDA decisions: 13
- 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)
- 1978: 4
- 1979: 5
- 1980: 2
- 1981: 2

## Most-cited predicates

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