510(k) · Cleared
ClearedSubmersible Reverse Osmosis Water Purification Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Filter/Continental Water Systems · FIP Subsystem, Water Purification
Cleared on Mar 13, 1990 after a 264-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Mar 13, 1990
- Review
- 264 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK894300 Submersible Reverse Osmosis Water Purification SysU.S. Filter/Continental Water Systems · 1990
- Descendant · cites it directly · 11 of its ownK991519 Ameriwater Purification System for HemodialysisAmeriwater · 2000
- Descendant · 2 generations on · 2 of its ownK111740 Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1…Ameriwater · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK133783 Ameriwater Centurion 1500+ Reverse Osmosis System with Heat…Ameriwater · 2014
- Descendant · 2 generations on · 0 of its ownK131622 Mroz Reverse Osmosis SystemAmeriwater · 2013
- Descendant · 2 generations on · 0 of its ownK123282 Deonization Exchange Tanks, Carbon Exchange TanksUltrapure & Industrial Services, LLC · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K991519Ameriwater Purification System for HemodialysisAmeriwater · 2000 · cites it directly11descendants
- K111740Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater · 2011 · 2 generations on2descendants
- K133783Ameriwater Centurion 1500+ Reverse Osmosis System with Heat SanitizationAmeriwater · 2014 · 3 generations on0descendants
- K131622Mroz Reverse Osmosis SystemAmeriwater · 2013 · 2 generations on0descendants
- K123282Deonization Exchange Tanks, Carbon Exchange TanksUltrapure & Industrial Services, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | 1990 | — |
| +1 | K991519 | Ameriwater Purification System for Hemodialysis | Ameriwater | 2000 | — |
| +2 | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station | Ameriwater | 2011 | 1 |
| +3 | K133783 | Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization | Ameriwater | 2014 | — |
| +2 | K131622 | Mroz Reverse Osmosis System | Ameriwater | 2013 | — |
| +2 | K123282 | Deonization Exchange Tanks, Carbon Exchange Tanks | Ultrapure & Industrial Services, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991519 | Ameriwater Purification System for Hemodialysis | 2000 | 11 |
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, K991519 (Ameriwater, 2000) has gone furthest, with 11 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/K894300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K894300: Submersible Reverse Osmosis Water Purification Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894300
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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