Nephros Inc
South Orange, NJ, US
NEPHROS, INC. appears in FDA device records in South Orange, NJ. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Nephros Inc between 2005 and 2022. The busiest year on record is 2016, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | KDI | Substantially Equivalent | |
| K161304 | EndoPur Filter | FIP | Substantially Equivalent | |
| K161467 | HydraGuard 10 UltraFilter | NHV | Substantially Equivalent | |
| K153084 | Nephros S100 | NHV | Substantially Equivalent | |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | NHV | Substantially Equivalent | |
| K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER | KDI | Substantially Equivalent | |
| K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | FIP | Substantially Equivalent | |
| K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | FIP | Substantially Equivalent | |
| K050603 | OLPUR DIALYZER, MODEL HD 190 | KDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003337893 | 3003337893 | NEPHROS, INC. | 380 Lackawana Place, South Orange, NJ 07079 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0488-2014 | 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose | Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. | Class I | Terminated | |
| Z-0487-2014 | Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose | Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. | Class I | Terminated | |
| Z-0490-2014 | Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking. | Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. | Class I | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Nephros Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain