Nephros Inc
FDA Regulatory Profile
Nephros Inc appears in FDA public data with 3 recalls — including 3 Class I (most serious) —, 9 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0487-2014, Class I) was initiated on Oct 28, 2013. Its most recent 510(k) clearance was granted on May 13, 2022.
Summary
- Total Recalls
- 3 (3 Class I)
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0487-2014 | Class I | Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : | Oct 28, 2013 |
| Z-0490-2014 | Class I | Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Us | Oct 28, 2013 |
| Z-0488-2014 | Class I | 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filter | Oct 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | May 13, 2022 |
| K161304 | EndoPur Filter | Mar 2, 2017 |
| K161467 | HydraGuard 10 UltraFilter | Dec 22, 2016 |
| K153084 | Nephros S100 | Apr 8, 2016 |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | Oct 24, 2014 |
| K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER | Apr 27, 2012 |
| K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | Jul 14, 2011 |
| K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | Jun 29, 2009 |
| K050603 | OLPUR DIALYZER, MODEL HD 190 | Jun 9, 2005 |