510(k) · Cleared
ClearedPall-Aquasafe Water Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pall International Sarl · NHV System, Water Purification, General Medical Use
Cleared on Jun 10, 2016 as substantially equivalent to K141731 (Nephros, Inc., 2014) after a 196-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Jun 10, 2016
- Review
- 196 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002045 (2001). 4 later devices descend from it, 3 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 deviceK153434 Pall-Aquasafe Water FilterPall International Sarl · 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
- Descendant · cites it directly · 0 of its ownK222727 i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH · 2023
- Descendant · cites it directly · 0 of its ownK163609 Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter…Pall International Sarl · 2017
Most influential descendants
Showing 4 of 4 · See all- K191563FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019 · cites it directly1descendant
- K261470QF10E.A.M Benelux B.V · 2026 · 2 generations on0descendants
- K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH · 2023 · cites it directly0descendants
- K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International Sarl · 2017 · cites it directly0descendants
View 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) | K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016 | — |
| +1 | K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019 | — |
| +2 | K261470 | QF10 | E.A.M Benelux B.V | 2026 | — |
| +1 | K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | I3 Membrane GmbH | 2023 | — |
| +1 | K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule… | Pall International Sarl | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K141731 | Nephros Dsu-H, Nephros Ssu-HSummary page 4…ct Code: NHV Device Classification: Class II Panel: Gastroenterology/Urology Predicate Devices: DSU-H and SSU-H Ultrafilters, K141731 Mainstream™ Water Purification Device, K012716 Section 006-Page 1 of 5… | 2014 |
| † | K012716 | Mainstream Water Purification Device | 2002 |
What descends from it? (4)
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 15 years and passes through 4 companies; a new generation was cleared every 1.6 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 Pall-Aquasafe Water Filter is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters 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 filters are 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/K153434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153434: Pall-Aquasafe Water Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153434
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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