Nephros, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Nephros, Inc.” (first 2005, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 165 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 260 |
| 2013 | 0 | — |
| 2014 | 1 | 119 |
| 2015 | 0 | — |
| 2016 | 2 | 187 |
| 2017 | 1 | 296 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 441 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nephros, Inc. took a median 368 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 199 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FIP | Subsystem, Water Purification | 3 | 3 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 3 | 3 |
| NHV | System, Water Purification, General Medical Use | 3 | 3 |
Review panels
Most recent Nephros, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | KDI | 2022-05-13 | 441 |
| K161304 | EndoPur Filter | FIP | 2017-03-02 | 296 |
| K161467 | HydraGuard 10 UltraFilter | NHV | 2016-12-22 | 209 |
| K153084 | Nephros S100 | NHV | 2016-04-08 | 165 |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | NHV | 2014-10-24 | 119 |
| K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER | KDI | 2012-04-27 | 260 |
| K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | FIP | 2011-07-14 | 164 |
| K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | FIP | 2009-06-29 | 90 |
| K050603 | OLPUR DIALYZER, MODEL HD 190 | KDI | 2005-06-09 | 92 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-10-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
NEPHROS INC (NEPH): EDGAR filings, CIK 1196298. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nephros, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Nephros, Inc.” (first 2005, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nephros, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nephros, Inc. is 165 days.
Which FDA product codes appear under Nephros, Inc.?
The most frequent FDA product codes under this applicant name are FIP (Subsystem, Water Purification, 3); KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 3); NHV (System, Water Purification, General Medical Use, 3).
Next steps
- See all 9 Nephros, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIP, Nephros, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.