# KMG: Purifier, Water, Ultraviolet, Medical

- Device class: 2; regulation: 21 CFR 880.6710; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1981: 6
- 1983: 2
- 2001: 1

## Most-cited predicates
- K813048: Aquanomics, #MP2SF (1981), cited by 1
- K813046: Aquanomics, #HHU60 (1981), cited by 1
- K813049: Aquanomics, #HHU100 (1981), cited by 1
- K813050: Aquanomics, #MP4SF (1981), cited by 1
- K813047: Aquanomics, Mini 60L (1981), cited by 1
- K813045: Aquanomics, #SP36SF (1981), cited by 1

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