Nephros, Inc.
Medical device manufacturer in South Orange, NJ.
9510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution FilterKDI · Traditional | 05/13/2022SE |
| K161304 | EndoPur FilterFIP · Traditional | 03/02/2017SE |
| K161467 | HydraGuard 10 UltraFilterNHV · Special | 12/22/2016SE |
| K153084 | Nephros S100NHV · Traditional | 04/08/2016SE |
| K141731 | Nephros Dsu-H, Nephros Ssu-HNHV · Traditional | 10/24/2014SE |
| K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterKDI · Traditional | 04/27/2012SE |
| K110285 | Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu FilterFIP · Special | 07/14/2011SE |
| K090885 | Nephros, Inc., Dsu Dual Stage UltrafilterFIP · Traditional | 06/29/2009SE |
| K050603 | Olpur Dialyzer, Model HD 190KDI · Traditional | 06/09/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0490-2014 Class I | Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2…Promotional materials for non-medical water filtration products were determined to promote claims which… | 10/28/2013Terminated |
| Z-0488-2014 Class I | 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH…Promotional materials for non-medical water filtration products were determined to promote claims which… | 10/28/2013Terminated |
| Z-0487-2014 Class I | Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661…Promotional materials for non-medical water filtration products were determined to promote claims which… | 10/28/2013Terminated |