510(k) · Cleared
ClearedGambro Water Purification Monitor WRD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro, Inc. · FIP Subsystem, Water Purification
Cleared on Jul 10, 1981 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.
- Decided
- Jul 10, 1981
- Review
- 25 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
- Descendant · cites it directly · 14 of its ownK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
- Descendant · 2 generations on · 13 of its ownK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
- Descendant · cites it directly · 12 of its ownK010131 PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…Aksys, Ltd. · 2002 · Recalled
- Descendant · 3 generations on · 6 of its ownK110578 Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 5 of its ownK124059 Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K042797Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005 · cites it directly14descendants
- K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010 · 2 generations on13descendants
- K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd. · 2002 · cites it directly12descendants
- K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · 3 generations on6descendants
- K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811678 | Gambro Water Purification Monitor WRD | Gambro, Inc. | 1981 | — |
| +1 | K042797 | Wro 300 Water Purification System for Hemodialysis | Gambro Renal Products | 2005 | — |
| +2 | K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 H | Gambro Renal Products, Inc. | 2010 | — |
| +1 | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment… | Aksys, Ltd. | 2002 | 1 |
| +3 | K110578 | Millenium HX Portable Reverse Osmosis Water Purification System | Mar Cor Purification, Inc. | 2011 | 1 |
| +3 | K124059 | Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT) | Lauer Membran Wassertechnik GmbH | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 282 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, K042797 (Gambro Renal Products, 2005) has gone furthest, with 14 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 | — |
https://510kreport.com/device/K811678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811678: Gambro Water Purification Monitor WRD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811678
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026