# K161304: EndoPur Filter

- Pathway: 510(k) (Traditional)
- Applicant: Nephros, Inc.
- Decided: Mar 2, 2017 after 296 days
- Product code: FIP (Subsystem, Water Purification)
- 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: 1 generation back to K954349 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954349: Fiberflo Hollow Fiber Cartridge Water Filters, Minntech Corp. (1995) Summary page 5.

## Indications for use
Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.). CONTRAINDICATIONS Heat sterilization is contraindicated for use with polypropylene housings that are not rated for disinfection temperatures above 80°C

Source page: https://510kreport.com/device/K161304
Methodology: https://510kreport.com/methodology