510(k) · Cleared
ClearedNephros Dsu-H, Nephros Ssu-H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nephros, Inc. · NHV System, Water Purification, General Medical Use
Cleared on Oct 24, 2014 as substantially equivalent to K012716 (Prismedical Corp., 2002) after a 119-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it.
- Decided
- Oct 24, 2014
- Review
- 119 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002045 (2001). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002045 Water Purification System for HemodialysisTotal Water Treatment Systems, Inc. · 2001
- 1 generation backK012716 Mainstream Water Purification DevicePrismedical Corp. · 2002
- This deviceK141731 Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK153784 Nosogard FiltersEvoqua Water Technologies, LLC · 2016
- Descendant · cites it directly · 4 of its ownK153434 Pall-Aquasafe Water FilterPall International Sarl · 2016
- Descendant · cites it directly · 2 of its ownK153084 Nephros S100Nephros, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK191563 FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019
- Descendant · 2 generations on · 1 of its ownK173164 Ecolab POU Water FilterEcolab, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K153784Nosogard FiltersEvoqua Water Technologies, LLC · 2016 · cites it directly4descendants
- K153434Pall-Aquasafe Water FilterPall International Sarl · 2016 · cites it directly4descendants
- K153084Nephros S100Nephros, Inc. · 2016 · cites it directly2descendants
- K191563FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019 · 2 generations on1descendant
- K173164Ecolab POU Water FilterEcolab, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | 2001 | — |
| −1 | K012716 | Mainstream Water Purification Device | Prismedical Corp. | 2002 | — |
| 0 (this device) | K141731 | Nephros Dsu-H, Nephros Ssu-H | Nephros, Inc. | 2014 | — |
| +1 | K153784 | Nosogard Filters | Evoqua Water Technologies, LLC | 2016 | — |
| +1 | K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016 | — |
| +1 | K153084 | Nephros S100 | Nephros, Inc. | 2016 | — |
| +2 | K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019 | — |
| +2 | K173164 | Ecolab POU Water Filter | Ecolab, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 NHV? 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 NHV device
- #1 K261470 QF10score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012716 | Mainstream Water Purification DeviceSummary page 5…6.5665 Water Purification Device, General and Number Medical Use Product Code NHV Predicate Device MainStream™ Water Purification Device – K012716 Reference Devices DSU and SSU Filters – K110285 Device Description The DSU-H and SSU-H Ultrafilters are hollow fiber u… | 2002 |
| † | K110285 | Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter | 2011 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153784 (Evoqua Water Technologies, LLC, 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K012716.
How does its category compare?
All NHV devicesNHV System, Water Purification, General Medical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NHV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NHV
203in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHV
No recall names NHV since 2007.
Adverse event reports per year · NHV
1in 2025
MAUDE reports naming product code NHV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 203 | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141731: Nephros Dsu-H, Nephros Ssu-H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141731
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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