510(k) · Cleared
ClearedMainstream Water Purification Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismedical Corp. · NHV System, Water Purification, General Medical Use
Cleared on May 7, 2002 as substantially equivalent to K002045 (Total Water Treatment Systems, Inc., 2001) after a 265-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.
- Decided
- May 7, 2002
- Review
- 265 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002045 (2001). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002045 Water Purification System for HemodialysisTotal Water Treatment Systems, Inc. · 2001
- This deviceK012716 Mainstream Water Purification DevicePrismedical Corp. · 2002
- Descendant · cites it directly · 9 of its ownK141731 Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK153784 Nosogard FiltersEvoqua Water Technologies, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK153434 Pall-Aquasafe Water FilterPall International Sarl · 2016
- Descendant · 2 generations on · 2 of its ownK153084 Nephros S100Nephros, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK191563 FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K141731Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014 · cites it directly9descendants
- K153784Nosogard FiltersEvoqua Water Technologies, LLC · 2016 · cites it directly4descendants
- K153434Pall-Aquasafe Water FilterPall International Sarl · 2016 · 2 generations on4descendants
- K153084Nephros S100Nephros, Inc. · 2016 · 2 generations on2descendants
- K191563FILTRAY 2G Disposable Water FiltersAqua-Tools · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | 2001 | — |
| 0 (this device) | K012716 | Mainstream Water Purification Device | Prismedical Corp. | 2002 | — |
| +1 | K141731 | Nephros Dsu-H, Nephros Ssu-H | Nephros, Inc. | 2014 | — |
| +1 | K153784 | Nosogard Filters | Evoqua Water Technologies, LLC | 2016 | — |
| +2 | K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016 | — |
| +2 | K153084 | Nephros S100 | Nephros, Inc. | 2016 | — |
| +2 | K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K002045 | Water Purification System for HemodialysisSummary page 1…: (707)258-0115 Contact Person: Elaine Alambra MainStream™ Water Purification Device Water Purification Device To be determined Total Water Treatment Systems (TWTS) — K002045 PriSMedical’s MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinkin… | 2001 |
What descends from it? (10)
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?
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.
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?
To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:
cleaning and rinsing open wounds;
infection control (cleaning equipment used in medical procedures, medical personnel’s hands);
use as a diluent for enteral, nutritional, oral vaccine or oral drug preparations; and
all other uses of sterile purified water the practitioner, or clinician deems necessary.
Not for parenteral administration.
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/K012716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012716: Mainstream Water Purification Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012716
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026