510(k) · Cleared
Recalled · Class II · 2021Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivonic GmbH · FIP Subsystem, Water Purification
Cleared on Apr 22, 2014 as substantially equivalent to K974899 (Gambro Healthcare, 1998) and 1 other predicate after a 126-day review. Its family tree reaches back 4 generations to 1981. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 22, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- FIP
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K811678 (1981). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
- 3 generations backK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
- 2 generations backK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
- 1 generation backK124059 Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013
- This deviceK133829 Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus&…Vivonic GmbH · 2014
- Descendant · cites it directly · 1 of its ownK213507 AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK252181 AquaAFresenius Medical Care North America · 2025
- Descendant · cites it directly · 0 of its ownK232953 AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K213507AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022 · cites it directly1descendant
- K252181AquaAFresenius Medical Care North America · 2025 · 2 generations on0descendants
- K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811678 | Gambro Water Purification Monitor WRD | Gambro, Inc. | 1981 | — |
| −3 | 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 | K124059 | Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT) | Lauer Membran Wassertechnik GmbH | 2013 | — |
| 0 (this device) | K133829 | Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus… | Vivonic GmbH | 2014 | — |
| +1 | K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022 | — |
| +2 | K252181 | AquaA | Fresenius Medical Care North America | 2025 | — |
| +1 | K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
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 |
|---|---|---|
| 2022 | 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? (2)
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 2…02A40140210 CWFS400k DINEN IMO N01=800 -DIN EN 3S01345207 VIVONIC Claiming substantial equivalence to K974899 Gambro CWP 100 reverse osmosis Ki124059 Lauer Aquaboss EcoRO Die 1+11 (HT) Device Description The AquaB… | 1998 |
| * | K124059 | Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Summary page 2…N 3S01345207 VIVONIC Claiming substantial equivalence to K974899 Gambro CWP 100 reverse osmosis Ki124059 Lauer Aquaboss EcoRO Die 1+11 (HT) Device Description The AquaBplus is a microcontroller-controlled, fully automati… | 2013 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2021 | Class II | Z-1364-2022 | Labeling Change Control | AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and… |
| Mar 18, 2021 | Class II | Z-1536-2021 | Labeling Change Control | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and… |
| Sep 1, 2020 | Class II | Z-0098-2021 | Process control | Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K213507 (Fresenius Medical Care Rental Therapies Group, LLC, 2022) has gone furthest, with 1 descendant 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. 2014, 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 AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133829
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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