Company ยท US
Nephros, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2022. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 13, 2022 | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter Nephros | KDI |
| Mar 2, 2017 | K161304 | EndoPur Filter Nephros, Inc. | FIP |
| Dec 22, 2016 | K161467 | HydraGuard 10 UltraFilter Nephros, Inc. | NHV |
| Apr 8, 2016 | K153084 | Nephros S100 Nephros, Inc. | NHV |
| Oct 24, 2014 | K141731 | NEPHROS DSU-H, NEPHROS SSU-H Nephros, Inc. | NHV |
| Apr 27, 2012 | K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER Nephros, Inc. | KDI |
| Jul 14, 2011 | K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER Nephros, Inc. | FIP |
| Jun 29, 2009 | K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER Nephros, Inc. | FIP |
| Jun 9, 2005 | K050603 | OLPUR DIALYZER, MODEL HD 190 Nephros, Inc. | KDI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | Nephros Inc 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
Ass Terminated |
ND | None listed |
| Dec 17, 2013 | Nephros Inc 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 b Terminated |
ND | None listed |
| Dec 17, 2013 | Nephros Inc 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 Terminated |
None listed |