# K161467: HydraGuard 10 UltraFilter

- Pathway: 510(k) (Special)
- Applicant: Nephros, Inc.
- Decided: Dec 22, 2016 after 209 days
- Product code: NHV (System, Water Purification, General Medical Use)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

Source page: https://510kreport.com/device/K161467
Methodology: https://510kreport.com/methodology