Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003337893

FEI Number

3003337893

Entity Name

NEPHROS, INC.

City/State/Country

South Orange, NJ, US

Establishment Address

380 Lackawana Place, South Orange, NJ 07079, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Nephros, INC. (Owner Number: 9053647)

Owner / Operator Contact Address

380 Lackawanna Place, South Orange, NJ 07079, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153084

PMA Number

N/A

All Registered Proprietary Names

EndoPur Endotoxin 30 Filter EndoPur Endotoxin 10 Filter EndoPur Endotoxin 20 Filter SSU-H UltraFilter DSU-H UltraFilter SSUmini UltraFilter SSU-D UltraFilter SSUmini JG UltraFilter DSU-D UltraFilter S100 In-Line S100 Shower Handheld S100 Sink Spray S100 Sink Spout

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2017-04-06
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2015-12-02
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2011-12-21
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2016-09-19

Official Correspondent

Vashone Thomas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nephros, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110578	Mar Cor Purification, Inc.	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	2011-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-05	Ameriwater Inc	2	AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number	Establishment Name	Location
3010867648	NELSON ENVIRONMENTAL TECHNOLOGIES, INC.	Arlington, TX, US
2135346	CULLIGAN SOFT WATER SERVICE CO.	Minnetonka, MN, US
3015349756	DIALITY, INC.	Irvine, CA, US
3003550196	Veolia Water Treatment & Solutions	ARLINGTON, TX, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003337893. Last updated year: 2026. Please use registration number 3003337893 when referencing this establishment in official correspondence.