510(k) · Cleared
ClearedQF10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.A.M Benelux B.V · NHV System, Water Purification, General Medical Use
Cleared on Sep 9, 2026 as substantially equivalent to K191563 (Aqua-Tools, 2019) after a 128-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Sep 9, 2026
- Review
- 128 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002045 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK002045 Water Purification System for HemodialysisTotal Water Treatment Systems, Inc. · 2001
- 4 generations backK012716 Mainstream Water Purification DevicePrismedical Corp. · 2002
- 3 generations backK141731 Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
- 2 generations backK153084 Nephros S100Nephros, Inc. · 2016
- 1 generation backK191563 FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019
- This deviceK261470 QF10E.A.M Benelux B.V · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | 2001 | — |
| −4 | K012716 | Mainstream Water Purification Device | Prismedical Corp. | 2002 | — |
| −3 | K141731 | Nephros Dsu-H, Nephros Ssu-H | Nephros, Inc. | 2014 | — |
| −2 | K153084 | Nephros S100 | Nephros, Inc. | 2016 | — |
| −1 | K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019 | — |
| 0 (this device) | K261470 | QF10 | E.A.M Benelux B.V | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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 K222727 i3 ONE (203100-S);i3 TWO connect (203200-S);i3…score 6.3 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K191563 | FILTRAY 2G Disposable Water FiltersSummary page 5…Panel: Gastroenterology/Urology Prescription Status: Rx Only III. PREDICATE DEVICE & REFERENCE DEVICE Primary Predicate Device: FILT’RAY 2G Disposable Water Filters (K191563) 21 CFR 876.5665, Class II, NHV Reference Device: Nephros DSU-H/SSU-H Point-of-Use Water Filters (K14173… | 2019 |
| † | K141731 | Nephros Dsu-H, Nephros Ssu-H | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
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. 2026, 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 QF10 is intended to be used to filter EPA-quality drinking water. By retaining bacteria, the filter may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), 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-grade sterile water.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261470: QF10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261470
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026