# K141731: Nephros Dsu-H, Nephros Ssu-H

- Pathway: 510(k) (Traditional)
- Applicant: Nephros, Inc.
- Decided: Oct 24, 2014 after 119 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
Longest line of descent: 2 generations back to K002045 (2001). 2 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012716: Mainstream Water Purification Device, Prismedical Corp. (2002) Summary page 5.

## Most influential descendants
- K153784: Nosogard Filters (2016), 4 descendants of its own
- K153434: Pall-Aquasafe Water Filter (2016), 4 descendants of its own
- K153084: Nephros S100 (2016), 2 descendants of its own
- K191563: FILTRAY 2G Disposable Water Filters (2019), 1 descendant of its own
- K173164: Ecolab POU Water Filter (2018), 1 descendant of its own

## Indications for use
The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.

Source page: https://510kreport.com/device/K141731
Methodology: https://510kreport.com/methodology