510(k) · Cleared
ClearedPortable Reverse Osmosis Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Water, Inc. · FIP Subsystem, Water Purification
Cleared on Jan 24, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 25 devices in its family, counting itself, has a Class I recall. 24 later devices descend from it.
- Decided
- Jan 24, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- This deviceK954928 Portable Reverse Osmosis MachineBetter Water, Inc. · 1996
- Descendant · cites it directly · 23 of its ownK032004 Aquaboss Ecoro Dia 50Lauer Ltd., Hong Kong · 2003
- Descendant · 2 generations on · 16 of its ownK140866 Tablo ConsoleHome Dialysis Plus · 2014
- Descendant · 3 generations on · 11 of its ownK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- Descendant · 4 generations on · 10 of its ownK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- Descendant · 5 generations on · 7 of its ownK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233335 Tablo® Hemodialysis System8 generations on · 2023
Most influential descendants
Showing 5 of 24 · See all- K032004Aquaboss Ecoro Dia 50Lauer Ltd., Hong Kong · 2003 · cites it directly23descendants
- K140866Tablo ConsoleHome Dialysis Plus · 2014 · 2 generations on16descendants
- K150880Tablo Console with Wireless CapabilityOutset Medical · 2015 · 3 generations on11descendants
- K160881Tablo ConsoleOutset Medical, Inc. · 2016 · 4 generations on10descendants
- K200741Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954928 | Portable Reverse Osmosis Machine | Better Water, Inc. | 1996 | — |
| +1 | K032004 | Aquaboss Ecoro Dia 50 | Lauer Ltd., Hong Kong | 2003 | — |
| +2 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| +3 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| +4 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| +5 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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), 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 14.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032004 | Aquaboss Ecoro Dia 50 | 2003 | 23 |
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 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032004 (Lauer Ltd., Hong Kong, 2003) has gone furthest, with 23 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/K954928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954928: Portable Reverse Osmosis Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954928
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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