510(k) Report

510(k) · Cleared

Cleared

Nephros, Inc., Dsu Dual Stage Ultrafilter

K090885510(k) TraditionalCleared Jun 29, 200990-day reviewClass II21 CFR 876.5665

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nephros, Inc. · FIP Subsystem, Water Purification

Cleared on Jun 29, 2009 as substantially equivalent to K983126 (Minntech Corp., 1999) after a 90-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it.

Decided
Jun 29, 2009
Review
90 days
Class
Class II
Product code
FIP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K983126 (1999). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2025: 2 descendants clearedK983126 · Fiberflo Hollow Fiber Capsule Water Filters · Minntech Corp. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K983126 · Fiberflo Hollow Fiber Capsule Water Filters · Minntech Corp. · 19990
  1. Root · 1 generation backK983126 Fiberflo Hollow Fiber Capsule Water FiltersMinntech Corp. · 1999
  2. This deviceK090885 Nephros, Inc., Dsu Dual Stage UltrafilterNephros, Inc. · 2009
  3. Descendant · cites it directly · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
  4. Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK210575 HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
  7. Descendant · 4 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 12022: 12024: 22025: 2
2012high 2 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · cites it directly5descendants
  • K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
  • K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
  • K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022 · 2 generations on1descendant
  • K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983126Fiberflo Hollow Fiber Capsule Water FiltersMinntech Corp.1999—
0 (this device)K090885Nephros, Inc., Dsu Dual Stage UltrafilterNephros, Inc.2009—
+1K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.2012—
+2K2315345008X Hemodialysis SystemFresenius Medical Care20241
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC20256
+2K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros2022—
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202210
202420
202520
FIG. 1 — Lineage of K090885, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FIP device

  1. #1 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K983126Fiberflo Hollow Fiber Capsule Water Filters
Summary page 1
…FiberFlo T M Hollow Fiber Cartridge Water Filters - K983126 Device Description The DSU Dual Stage Ultrafilter is a hollow fiber filter that removes bact…
Minntech Corp.1999—

Also cleared against K983126: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K112314 (Nephros, Inc., 2012) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K983126.

How does its category compare?

All FIP devices

FIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FIP

4in 2025

2007: 12008: 32009: 32010: 22011: 42012: 22013: 42014: 42015: 22016: 22017: 12018: 12019: 22020: 12021: 12022: 12023: 32024: 12025: 4
2007high 4 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIP

88in 2025

2008: 202 days median2009: 167 days median2011: 116 days median2013: 125 days median2014: 126 days median2023: 69 days median2025: 88 days median
2007high 202 (2008) · low 69 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FIP

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FIP

77in 2025

2007: 12008: 52010: 122011: 42012: 42013: 412014: 342015: 122016: 32017: 62018: 32019: 132020: 122021: 352022: 572023: 1402024: 1742025: 77
2007high 174 (2024) · low 0 (2009)2025

MAUDE reports naming product code FIP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
2008320205
2009316700
20102—012
2011411604
20122—04
20134125041
20144126034
20152—012
20162—03
20171—06
20181—03
20192—013
20201—112
20211—035
20221—057
20233690140
20241—0174
2025488077
20260—0—

What is it indicated for?

The DSU Dual Stage Ultrafilter is intended to be used to filter water or bicarbonate concentrate

used in hemodialysis devices. The DSU Ultrafilter assists in providing hemodialysis quality water

or bicarbonate concentrate. The device is not a complete water treatment system, but serves to

remove biological contaminants. Therefore, it must be used in conjunction with other water

treatment equipment (i.e., RO, DI, etc.).

Indications for use as stated in the FDA summary.

Also cleared against K983126

2 other devices cite the same predicate.

  • K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012
  • K052764Diacap Ultra Dialysis Fluid FilterB. Braun Medizintechnologie GmbH · 20061 recall

More from Nephros, Inc.

8 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in FIP

The FIP category page

  • K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC · 2025
  • K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  • K252181AquaAFresenius Medical Care North America · 2025
  • K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
  • K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024

https://510kreport.com/device/K090885 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090885: Nephros, Inc., Dsu Dual Stage Ultrafilter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090885

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026