510(k) · Cleared
ClearedMatrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Water, Inc. · FIP Subsystem, Water Purification
Cleared on Nov 18, 2005 as substantially equivalent to K920186 (Better Water, Inc., 1995) and 2 other predicates after a 154-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 18, 2005
- Review
- 154 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K944385 (1995). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944385 MD400 a/B/C/D/E/F/GInternational Purification Systems, Inc. · 1995
- 1 generation backK993200 MD 420/440/460/470/480/490Isopure, Corp. · 2000
- This deviceK051620 Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd…Better Water, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK151637 UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015
- Descendant · 2 generations on · 0 of its ownK250514 UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK161844 Matrix Pre-Treatment ControllerBetter Water, LLC · 2016
Most influential descendants
Showing 3 of 3 · See all- K151637UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015 · cites it directly1descendant
- K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025 · 2 generations on0descendants
- K161844Matrix Pre-Treatment ControllerBetter Water, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944385 | MD400 a/B/C/D/E/F/G | International Purification Systems, Inc. | 1995 | — |
| −1 | K993200 | MD 420/440/460/470/480/490 | Isopure, Corp. | 2000 | — |
| 0 (this device) | K051620 | Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series | Better Water, Inc. | 2005 | — |
| +1 | K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015 | — |
| +2 | K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025 | — |
| +1 | K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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 FIP? 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 FIP device
- #1 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K920186 | Water Purification System for HemodialysisSummary page 2…Digital Reverse Osmosis Water Treatment System is based upon the technology of the Water Purification System For Hemodialysis manufacturered by Better Water (K920186) with respect to "wetted-contact materials", pump size and the selection of the type and number of membranes. Additional… | 1995 |
| * | K993200 | MD 420/440/460/470/480/490Summary page 2…with firmware as well as an Operator Interface Touch Screen. These electronic features are equivalent to the electronic features incorporated in the MD 400 (K993200) and 600 (K041163) Series Water Systems manufactured by Isopure Incorporated. See the table below for detailed comparison… | 2000 |
| * | K041163 | Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 SeriesSummary page 2…as well as an Operator Interface Touch Screen. These electronic features are equivalent to the electronic features incorporated in the MD 400 (K993200) and 600 (K041163) Series Water Systems manufactured by Isopure Incorporated. See the table below for detailed comparison.… | 2004 |
What descends from it? (3)
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 10 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151637 (Specialty Water Technologies, 2015) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K920186.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, 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 | 1 | — | 0 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051620: Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051620
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