510(k) · Cleared
ClearedAseptech Portable RO+ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dayton Water Systems · FIP Subsystem, Water Purification
Cleared on Aug 24, 1995 after a 1,071-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 24, 1995
- Review
- 1,071 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK924695 Aseptech Portable RO+ SystemDayton Water Systems · 1995
- Descendant · cites it directly · 2 of its ownK111740 Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1…Ameriwater · 2011 · Recalled
- Descendant · cites it directly · 1 of its ownK030059 Portable RO+ Model MROS09Ameriwater · 2003
- Descendant · 2 generations on · 0 of its ownK133783 Ameriwater Centurion 1500+ Reverse Osmosis System with Heat…Ameriwater · 2014
- Descendant · cites it directly · 0 of its ownK131622 Mroz Reverse Osmosis SystemAmeriwater · 2013
- Descendant · 2 generations on · 0 of its ownK042089 NX Stage Water Purification SystemNxstage Medical, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K111740Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater · 2011 · cites it directly2descendants
- K030059Portable RO+ Model MROS09Ameriwater · 2003 · cites it directly1descendant
- K133783Ameriwater Centurion 1500+ Reverse Osmosis System with Heat SanitizationAmeriwater · 2014 · 2 generations on0descendants
- K131622Mroz Reverse Osmosis SystemAmeriwater · 2013 · cites it directly0descendants
- K042089NX Stage Water Purification SystemNxstage Medical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924695 | Aseptech Portable RO+ System | Dayton Water Systems | 1995 | — |
| +1 | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station | Ameriwater | 2011 | 1 |
| +1 | K030059 | Portable RO+ Model MROS09 | Ameriwater | 2003 | — |
| +2 | K133783 | Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization | Ameriwater | 2014 | — |
| +1 | K131622 | Mroz Reverse Osmosis System | Ameriwater | 2013 | — |
| +2 | K042089 | NX Stage Water Purification System | Nxstage Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K111740 (Ameriwater, 2011) has gone furthest, with 2 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/K924695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924695: Aseptech Portable RO+ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924695
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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