510(k) · Cleared
ClearedAquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lauer Membran Wassertechnik GmbH · FIP Subsystem, Water Purification
Cleared on Mar 25, 2013 as substantially equivalent to K974899 (Gambro Healthcare, 1998) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1981. 5 later devices descend from it.
- Decided
- Mar 25, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K811678 (1981). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
- 2 generations backK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
- 1 generation backK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
- This deviceK124059 Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013
- Descendant · cites it directly · 3 of its ownK133829 Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus&…Vivonic GmbH · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK213507 AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK252181 AquaAFresenius Medical Care North America · 2025
- Descendant · 2 generations on · 0 of its ownK232953 AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024
- Descendant · cites it directly · 0 of its ownK223479 AQUAbase nXB.Braun Medical, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH · 2014 · cites it directly3descendants
- K213507AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022 · 2 generations on1descendant
- K252181AquaAFresenius Medical Care North America · 2025 · 3 generations on0descendants
- K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024 · 2 generations on0descendants
- K223479AQUAbase nXB.Braun Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811678 | Gambro Water Purification Monitor WRD | Gambro, Inc. | 1981 | — |
| −2 | K042797 | Wro 300 Water Purification System for Hemodialysis | Gambro Renal Products | 2005 | — |
| −1 | K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 H | Gambro Renal Products, Inc. | 2010 | — |
| 0 (this device) | K124059 | Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT) | Lauer Membran Wassertechnik GmbH | 2013 | — |
| +1 | K133829 | Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus… | Vivonic GmbH | 2014 | 3 |
| +2 | K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022 | — |
| +3 | K252181 | AquaA | Fresenius Medical Care North America | 2025 | — |
| +2 | K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
| +1 | K223479 | AQUAbase nX | B.Braun Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K974899 | Gambro Central Water Treatment System CWP 100 - Wro HSummary page 1…s Water Purification System for Hemodialysis Claiming substantial equivalence to: Gambro, Central Water Treatment System CWP 100 WROH (K974899), Gambro WRO 300H (K093608) Aquaboss EcoflO Dia (… | 1998 |
| * | K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 HSummary page 1…sis Claiming substantial equivalence to: Gambro, Central Water Treatment System CWP 100 WROH (K974899), Gambro WRO 300H (K093608) Aquaboss EcoflO Dia (K032004)… | 2010 |
| * | K032004 | Aquaboss Ecoro Dia 50Summary page 1…tment System CWP 100 WROH (K974899), Gambro WRO 300H (K093608) Aquaboss EcoflO Dia (K032004) 2635… | 2003 |
What descends from it? (5)
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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K133829 (Vivonic GmbH, 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K974899.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Aquaboss® EcoRO I, EcoRO I HT, EcoRO Die 11and EcoRO Die 11HT are complete water treatment systems centered around reverse osmosis units of varying output which Include recommended pretreatment components such as carbon filtration, backwash filters, softeners, and temperature blending valves and recommended post treatment such as final filtration intended for hemodialysis applications. The AquabostP water treatment systems are to be used at dialysis…
Read the full statement (442 words)
The Aquaboss® EcoRO I, EcoRO I HT, EcoRO Die 11and EcoRO Die 11HT are complete water treatment systems centered around reverse osmosis units of varying output which Include recommended pretreatment components such as carbon filtration, backwash filters, softeners, and temperature blending valves and recommended post treatment such as final filtration intended for hemodialysis applications.
The AquabostP water treatment systems are to be used at dialysis clinics or hospitals.
The Aquaboss' EcoRO 1,EcaRO I HT, EcoRO Dia 11and EcoRO Die 11HT are intended to remove organic and inorganic substances and microbial contaminants from water. The treated water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple uses and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers.
The water treatment systems are designed to meet current AAMI/ISO and Federal (U.S.) standards.
The Aquabosso water treatment systems come In the following configurations:
(1) EcoRO I: Single-Pass / Single staged: Chemical Disinfection -
Catalogue numbers:
1106073- 1109093-1106108 -1106128- 1106143 -1106183- 1106213 - 1106248 - 1106283 - 1106363
Description:
Single staged reverse osmosis with permeate capacity of 700 Ith to 3600 Ul.
Chemical disinfection possible.
Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves.
Post-treatment: Ringmain with optional final filtration for distribution of permeate to paint of use.
(2) EcoRO 11Twin-Pass / Double Staged Chemical Disinfection
Catalogue numbers:
1107073-1107094-1107108- 1101128- 1107143-1107184- 1107214-1107249 -1107283-1107363
Dual/ Double staged reverse osmosis with permeate capacity of 700 I/h to 3600 V/,
Chemical Disinfection possible.
Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves.
Past-treatment: Ringmain with optional final filtration for distribution of permeate to point of use.
(3) EcoRO I HT Single-Pass / Single Staged Heat Disinfection
Catalogue numbers:
1106072 -1106092 -1106107 -1106127 -1106142 -1106182 -1106212 -1106247- 1106282 -1106362
Description:
Single staged reverse osmosis with permeate capacity of 700 I/h to 3600 Vl.
Chemical disinfection possible
Hot water sanitization with Aquaboss HotRinse SMART 10/ 20/30/40/60.
Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves.
Post-treatment: Ringmain with optional final filtration for distribution of permeate to point of use.
(4) EcoRO 11HT Twin-Pass / Double Staged Chemical Disinfection
Catalogue numbers:
1107072 -1107093- 1107107 -1107142 -1107183 -1107213 -1107248 -1107282- 1107362
Description:
Dual! Double staged reverse osmosis with permeate capacity of 700 I/h to 3600 Vl.
Chemical disinfection possible
H-ot water sanitization with AquabossP HotRinse SMART 10/ 20/30/40/60.
Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves.
Post-treatment: Ringmain with optional final filtration for distribution of permeate to point of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124059: Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124059
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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