Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nephros, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
296 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161304 | EndoPur Filter | Nephros, Inc. | 2017-03-02 | 296 | 0 |
| K161467 | HydraGuard 10 UltraFilter | Nephros, Inc. | 2016-12-22 | 209 | 0 |
| K153084 | Nephros S100 | Nephros, Inc. | 2016-04-08 | 165 | 0 |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | Nephros, Inc. | 2014-10-24 | 119 | 0 |
| K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR M | Nephros, Inc. | 2012-04-27 | 260 | 0 |
| K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | Nephros, Inc. | 2011-07-14 | 164 | 0 |
| K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | Nephros, Inc. | 2009-06-29 | 90 | 0 |
| K050603 | OLPUR DIALYZER, MODEL HD 190 | Nephros, Inc. | 2005-06-09 | 92 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda