# K153084: Nephros S100

- Pathway: 510(k) (Traditional)
- Applicant: Nephros, Inc.
- Decided: Apr 8, 2016 after 165 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: 3 generations back to K002045 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141731: Nephros Dsu-H, Nephros Ssu-H, Nephros, Inc. (2014) Summary page 4.

## Most influential descendants
- K191563: FILTRAY 2G Disposable Water Filters (2019), 1 descendant of its own
- K261470: QF10 (2026), 0 descendants of its own

## Indications for use
The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands. 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/K153084
Methodology: https://510kreport.com/methodology