510(k) · Cleared
ClearedWater Purification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Water & Power Technologies, Inc. · FIP Subsystem, Water Purification
Cleared on Jan 2, 2001 as substantially equivalent to K945559 (Mar Cor Services, Inc., 1996) after a 378-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Jan 2, 2001
- Review
- 378 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873487 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK873487 HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 1987
- 1 generation backK945559 Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996
- This deviceK994292 Water Purification SystemWater & Power Technologies, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK042089 NX Stage Water Purification SystemNxstage Medical, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042089NX Stage Water Purification SystemNxstage Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873487 | HD-400-a/B/C Hemodialysis Systems & Accessories | Water Pure, Inc. | 1987 | — |
| −1 | K945559 | Mar Cor Complete Water Treatment System for Kdney Dialysis | Mar Cor Services, Inc. | 1996 | — |
| 0 (this device) | K994292 | Water Purification System | Water & Power Technologies, Inc. | 2001 | — |
| +1 | K042089 | NX Stage Water Purification System | Nxstage Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 14.1 · 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? (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 |
|---|---|---|---|
| * | K945559 | Mar Cor Complete Water Treatment System for Kdney DialysisSummary page 1…ialysis Legally marketed predicate device to which substantial equivalence is claimed: Mar Cor Services, Inc. Complete Water Treatment System for Kidney Dialysis (Ref. K945559) Description of the device that is the subject of this premarket notification: The WPT Water purification System has been develo… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042089 | NX Stage Water Purification System | 2004 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042089 (Nxstage Medical, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K945559.
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 device is intended to remove organic and inorganic substances and-microbiai contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing and equipment srinse and disinfection.
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/K994292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994292: Water Purification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994292
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