510(k) · Cleared
ClearedHydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydropure Systems, Inc. · FIP Subsystem, Water Purification
Cleared on Feb 11, 2003 after a 176-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Feb 11, 2003
- Review
- 176 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK022747 Hydropure Portable Exchange Deionization (Pedi) System; Hydropure…Hydropure Systems, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK042089 NX Stage Water Purification SystemNxstage Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK031832 Mega Pure CartMega Services · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022747 | Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi… | Hydropure Systems, Inc. | 2003 | — |
| +1 | K042089 | NX Stage Water Purification System | Nxstage Medical, Inc. | 2004 | — |
| +1 | K031832 | Mega Pure Cart | Mega Services | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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? (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 |
|---|---|---|---|
| * | — | US Filter Corporation’s water treatment system for dialysis Named without a submission number |
What descends from it? (2)
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?
- Of its descendants, K042089 (Nxstage Medical, Inc., 2004) has gone furthest, with 0 descendants of its own.
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 HydroPure “Acute” Portable Exchange Deionization (PEDI) System consists of two each small carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be placed on the back of a dialysis machine or on a handcart for single patient dialysis. The HydroPure “Central” PEDI System consists of two or more carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be installed in a central location for multiple patient…
Read the full statement (193 words)
The HydroPure “Acute” Portable Exchange Deionization (PEDI) System consists of two each small carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be placed on the back of a dialysis machine or on a handcart for single patient dialysis.
The HydroPure “Central” PEDI System consists of two or more carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be installed in a central location for multiple patient dialysis.
The HydroPure “Back-up” PEDI System consists of two or more mixed bed DI tanks as a component in a “back-up” condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions that an RO could not lower to safe levels.
All three PEDI systems with appropriate pre & post-filtration and components is intended for use with a hemodialysis system to remove organic and inorganic substances from water that is used to dilute dialysis concentrates to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022747 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022747: Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022747
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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