510(k) · Cleared
ClearedAquaboss Ecoro Dia 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lauer Ltd., Hong Kong · FIP Subsystem, Water Purification
Cleared on Oct 2, 2003 as substantially equivalent to K954928 (Better Water, Inc., 1996) after a 94-day review. Its family tree reaches back 1 generation to 1996. 1 of the 25 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 94 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954928 (1996). 23 later devices descend from it, 2 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK954928 Portable Reverse Osmosis MachineBetter Water, Inc. · 1996
- This deviceK032004 Aquaboss Ecoro Dia 50Lauer Ltd., Hong Kong · 2003
- Descendant · cites it directly · 16 of its ownK140866 Tablo ConsoleHome Dialysis Plus · 2014
- Descendant · 2 generations on · 11 of its ownK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- Descendant · 3 generations on · 10 of its ownK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- Descendant · 4 generations on · 7 of its ownK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 6 of its ownK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233335 Tablo® Hemodialysis System7 generations on · 2023
Most influential descendants
Showing 5 of 23 · See all- K140866Tablo ConsoleHome Dialysis Plus · 2014 · cites it directly16descendants
- K150880Tablo Console with Wireless CapabilityOutset Medical · 2015 · 2 generations on11descendants
- K160881Tablo ConsoleOutset Medical, Inc. · 2016 · 3 generations on10descendants
- K200741Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · 4 generations on7descendants
- K211370Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954928 | Portable Reverse Osmosis Machine | Better Water, Inc. | 1996 | — |
| 0 (this device) | K032004 | Aquaboss Ecoro Dia 50 | Lauer Ltd., Hong Kong | 2003 | — |
| +1 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| +2 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| +3 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| +4 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
| +5 | K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 1 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K954928 | Portable Reverse Osmosis MachineSummary page 1…Inc. Water Treatment System for Hemodialysis Medi-Port PB (K954928) Lauer Membran Wassertechnik GmbH SpeichenatI9 79599 Wittlingen 09_510(k) summary rv4… | 1996 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K140866 (Home Dialysis Plus, 2014) has gone furthest, with 16 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 | — |
What is it indicated for?
Aquaboss@EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is a device that is intended for use with a hemodialysis system. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.
The device includes carbon filter and sediment filter. The device may include a water softener.
Aquaboss@EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is designed for the use in hospital or in home settings.
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/K032004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032004: Aquaboss Ecoro Dia 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032004
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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