510(k) Report

FDA applicant

Nephros, Inc.

River Edge, NJ9 decisions2005–20220 recalls

FDA records 9 decisions for Nephros, Inc. (River Edge, NJ) from 2005 to 2022: 9 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FIP (Subsystem, Water Purification). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nephros”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Nephros, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2009: 12011: 12012: 12014: 12016: 22017: 12022: 1
2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nephros, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nephros, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System3decisions
  • FIPSubsystem, Water Purification3decisions
  • NHVSystem, Water Purification, General Medical Use3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 209 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 203 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141731Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 20143cite it
  • K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 20122cite it
  • K050603Olpur Dialyzer, Model HD 190Nephros, Inc. · 20051cites it
  • K090885Nephros, Inc., Dsu Dual Stage UltrafilterNephros, Inc. · 20091cites it
  • K153084Nephros S100Nephros, Inc. · 20161cites it
  • K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 20221cites it

What has FDA decided for it lately?

  • K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
  • K161304EndoPur FilterNephros, Inc. · 2017
  • K161467HydraGuard 10 UltraFilterNephros, Inc. · 2016
  • K153084Nephros S100Nephros, Inc. · 2016
  • K141731Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
  • K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012
  • K110285Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu FilterNephros, Inc. · 2011
  • K090885Nephros, Inc., Dsu Dual Stage UltrafilterNephros, Inc. · 2009

All 8 as Nephros, Inc. →The one decision as Nephros →