510(k) · Cleared
ClearedGambro Water Purification Unit, Models Wro 300 and Wro 300 H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products, Inc. · FIP Subsystem, Water Purification
Cleared on Jul 29, 2010 as substantially equivalent to K042797 (Gambro Renal Products, 2005) after a 251-day review. Its family tree reaches back 2 generations to 1981. 13 later devices descend from it.
- Decided
- Jul 29, 2010
- Review
- 251 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811678 (1981). 13 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
- 1 generation backK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
- This deviceK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK110578 Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · Recalled
- Descendant · cites it directly · 5 of its ownK124059 Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013
- Descendant · 2 generations on · 3 of its ownK133829 Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus&…Vivonic GmbH · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK213507 AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK171099 EON Portable Reverse Osmosis Water Purification SystemCantel · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · cites it directly6descendants
- K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013 · cites it directly5descendants
- K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH · 2014 · 2 generations on3descendants
- K213507AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022 · 3 generations on1descendant
- K171099EON Portable Reverse Osmosis Water Purification SystemCantel · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811678 | Gambro Water Purification Monitor WRD | Gambro, Inc. | 1981 | — |
| −1 | K042797 | Wro 300 Water Purification System for Hemodialysis | Gambro Renal Products | 2005 | — |
| 0 (this device) | K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 H | Gambro Renal Products, Inc. | 2010 | — |
| +1 | K110578 | Millenium HX Portable Reverse Osmosis Water Purification System | Mar Cor Purification, Inc. | 2011 | 1 |
| +1 | K124059 | Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT) | Lauer Membran Wassertechnik GmbH | 2013 | — |
| +2 | K133829 | Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus… | Vivonic GmbH | 2014 | 3 |
| +3 | K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022 | — |
| +2 | K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K042797 | Wro 300 Water Purification System for HemodialysisSummary page 2…Subsystem, Water treatment Device Class 11 Product Code 78FIP Regulation Number 876.5665 510(k) number K042797 ______ WRO 300 WRO 300 H… | 2005 |
What descends from it? (13)
See all 135 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 29 years and passes through 3 companies; a new generation was cleared every 23.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110578 (Mar Cor Purification, Inc., 2011) has gone furthest, with 6 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. 2010, this device’s year, is highlighted.
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 Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment. WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards. The Gambro WRO 300 H Water…
Read the full statement (138 words)
The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.
WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.
The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.
WTRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.
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/K093608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093608
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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