Data / Medical devices / United States / Nephros, Inc.
Nephros, Inc.: FDA-registered device maker in South Orange, NJ, United States, 6 510(k) clearances
Nephros, Inc. is registered with the FDA (registration 3003337893) in South Orange, NJ, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 2, 2017. 2 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003337893
- Address
- 380 Lackawana Place, South Orange, NJ, United States, 07079
- Owner or operator
- Nephros, INC. (9053647)
- Roles
- Complaint file establishment, Contract manufacturer, Specification developer
- First device listed
- December 21, 2011
- Registered through
- 2026
- Brand names listed
- DSU-D UltraFilter, DSU-H UltraFilter, EndoPur Endotoxin 10 Filter, EndoPur Endotoxin 20 Filter, EndoPur Endotoxin 30 Filter, H2H Infusion Set, H2H Rinse Line, H2H Substitution Filter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| System, Water Purification, General Medical Use | NHV | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2017 | K161304 | EndoPur Filter | FIP | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
| December 22, 2016 | K161467 | HydraGuard 10 UltraFilter | NHV | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
| April 8, 2016 | K153084 | Nephros S100 | NHV | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
| October 24, 2014 | K141731 | NEPHROS DSU-H, NEPHROS SSU-H | NHV | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
| April 27, 2012 | K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER | KDI | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
| July 14, 2011 | K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | FIP | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 28, 2013 | 66736 | Class I | Terminated | 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 b | Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. | accessdata.fda.gov |
| October 28, 2013 | 66735 | Class I | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Subsystem, Water Purification
- All makers of System, Water Purification, General Medical Use
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
Updated March 2, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.