510(k) · Cleared
ClearedNosogard Filters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evoqua Water Technologies, LLC · NHV System, Water Purification, General Medical Use
Cleared on Oct 21, 2016 as substantially equivalent to K141731 (Nephros, Inc., 2014) and 1 other predicate after a 295-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Oct 21, 2016
- Review
- 295 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002045 (2001). 4 later devices descend from it, 2 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 deviceK153784 Nosogard FiltersEvoqua Water Technologies, LLC · 2016
- Descendant · cites it directly · 1 of its ownK191563 FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019
- Descendant · cites it directly · 1 of its ownK173164 Ecolab POU Water FilterEcolab, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK261470 QF10E.A.M Benelux B.V · 2026
- Descendant · 2 generations on · 0 of its ownK182164 Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle…Ecolab, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K191563FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019 · cites it directly1descendant
- K173164Ecolab POU Water FilterEcolab, Inc. · 2018 · cites it directly1descendant
- K261470QF10E.A.M Benelux B.V · 2026 · 2 generations on0descendants
- K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU…Ecolab, Inc. · 2019 · 2 generations on0descendants
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) | K153784 | Nosogard Filters | Evoqua Water Technologies, LLC | 2016 | — |
| +1 | K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019 | — |
| +1 | K173164 | Ecolab POU Water Filter | Ecolab, Inc. | 2018 | — |
| +2 | K261470 | QF10 | E.A.M Benelux B.V | 2026 | — |
| +2 | K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet… | Ecolab, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 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? (2)
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…ice, and Number General Medical Use Product Code NHV Predicate Device 1 Nephros Inc. – DSU-HTM and SSU-HTM Filters – K141731 Predicate Device 2 PrisMedical – MainStreamTM Water Purification Device – K012716 Device Description No… | 2014 |
| * | K012716 | Mainstream Water Purification DeviceSummary page 4…Predicate Device 1 Nephros Inc. – DSU-HTM and SSU-HTM Filters – K141731 Predicate Device 2 PrisMedical – MainStreamTM Water Purification Device – K012716 Device Description Nosogard Filters are disposable Polyethersulfone (PES) membrane f… | 2002 |
What descends from it? (4)
2 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 2.0 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 NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of…
Read the full statement (115 words)
The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired.
The Nosogard is not intended for use in the production of USP sterile water for use in infusion, injection or production of fluids for use in dialysis treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153784: Nosogard Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153784
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