510(k) · Cleared
ClearedPure Water, Inc.'S Water Purification Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pure Water, Inc. · FIP Subsystem, Water Purification
Cleared on Jan 24, 2000 as substantially equivalent to K920186 (Better Water, Inc., 1995) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 24, 2000
- Review
- 158 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920186 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920186 Water Purification System for HemodialysisBetter Water, Inc. · 1995
- This deviceK992786 Pure Water, Inc.'S Water Purification SystemsPure Water, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920186 | Water Purification System for Hemodialysis | Better Water, Inc. | 1995 | — |
| 0 (this device) | K992786 | Pure Water, Inc.'S Water Purification Systems | Pure Water, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K920186 | Water Purification System for HemodialysisSummary page 1…dialysis Equivalency: The Pure Water, Inc. Water Purification System is substantially equivalent to Better Water's Water Purification System for Hemodialysis (510(k) #: K920186) and ZyzaTech Water System, Inc.’s Water Purification Systems and Components and Portable Reverse Osmosis Systems (510(k) #: K964… | 1995 |
| * | K964539 | Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802…Summary page 1…n System for Hemodialysis (510(k) #: K920186) and ZyzaTech Water System, Inc.’s Water Purification Systems and Components and Portable Reverse Osmosis Systems (510(k) #: K964539), which are currently in commercial distribution. Device Description: The Pure Water, Inc. Water Purification System uses Rever… | 1997 |
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?
- None of the 2 ancestors has a recall.
- 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 Pure Water, Inc. Water Purification System is intended to be used in Hemodialysis facilities for the purification of water to be used to dilute dialysate concentrate and in the
reprocessing of dialyzers for reuse.
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/K992786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992786: Pure Water, Inc.'S Water Purification Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992786
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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