510(k) · Cleared
ClearedAQUAbase nX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FIP Subsystem, Water Purification
Cleared on Aug 16, 2023 as substantially equivalent to K124059 (Lauer Membran Wassertechnik GmbH, 2013) after a 271-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Aug 16, 2023
- Review
- 271 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K811678 (1981). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK223479 AQUAbase nXB.Braun Medical, Inc. · 2023
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) | 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 |
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 14.1 · 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 |
|---|---|---|---|
| * | K124059 | Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Summary page 5…nX ____________________________________________________________________________________________ III. PREDICATE DEVICE Aquaboss (Eco)RO Dia I + II (HT) 510(k) number: K124059 IV. DEVICE DESCRIPTION The AQUAbase nX is a single stage reverse osmosis system. A graphical touchscreen allows access and moni… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 5 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K124059.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by…
Read the full statement (121 words)
The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals
The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well.
The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223479: AQUAbase nX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223479
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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