# NHV: System, Water Purification, General Medical Use

- Device class: 2; regulation: 21 CFR 876.5665; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 267 days (middle half 267–267)
- 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)
- 2002: 1
- 2014: 1
- 2016: 4
- 2017: 1
- 2018: 1
- 2019: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- K153434: Pall-Aquasafe Water Filter (2016), cited by 3
- K141731: Nephros Dsu-H, Nephros Ssu-H (2014), cited by 3
- K153784: Nosogard Filters (2016), cited by 2
- K012716: Mainstream Water Purification Device (2002), cited by 2
- K153084: Nephros S100 (2016), cited by 1
- K191563: FILTRAY 2G Disposable Water Filters (2019), cited by 1
- K173164: Ecolab POU Water Filter (2018), cited by 1

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