510(k) · Cleared
ClearedNephros S100
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 Apr 8, 2016 as substantially equivalent to K141731 (Nephros, Inc., 2014) after a 165-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Apr 8, 2016
- Review
- 165 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002045 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK002045 Water Purification System for HemodialysisTotal Water Treatment Systems, Inc. · 2001
- 2 generations backK012716 Mainstream Water Purification DevicePrismedical Corp. · 2002
- 1 generation backK141731 Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
- This deviceK153084 Nephros S100Nephros, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK191563 FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019
- Descendant · 2 generations on · 0 of its ownK261470 QF10E.A.M Benelux B.V · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | 2001 | — |
| −2 | K012716 | Mainstream Water Purification Device | Prismedical Corp. | 2002 | — |
| −1 | K141731 | Nephros Dsu-H, Nephros Ssu-H | Nephros, Inc. | 2014 | — |
| 0 (this device) | K153084 | Nephros S100 | Nephros, Inc. | 2016 | — |
| +1 | K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019 | — |
| +2 | K261470 | QF10 | E.A.M Benelux B.V | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K141731 | Nephros Dsu-H, Nephros Ssu-HSummary page 4…21 CFR Part 876.5665 Water Purification Device, General and Number Medical Use Product Code NHV Predicate Device DSU-H and SSU-H Ultrafilters – K141731 Device Description The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191563 | FILTRAY 2G Disposable Water Filters | 2019 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191563 (Aqua-Tools, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K141731.
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. 2016, 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 S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filter is 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/K153084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153084: Nephros S100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153084
Report an extraction error
Are you the manufacturer?
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