510(k) · Cleared
ClearedDeonization Exchange Tanks, Carbon Exchange Tanks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrapure & Industrial Services, LLC · FIP Subsystem, Water Purification
Cleared on Apr 25, 2013 as substantially equivalent to K991519 (Ameriwater, 2000) after a 185-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 25, 2013
- Review
- 185 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894300 (1990). No later device cites it as a predicate yet.
- Root · 2 generations backK894300 Submersible Reverse Osmosis Water Purification SysU.S. Filter/Continental Water Systems · 1990
- 1 generation backK991519 Ameriwater Purification System for HemodialysisAmeriwater · 2000
- This deviceK123282 Deonization Exchange Tanks, Carbon Exchange TanksUltrapure & Industrial Services, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | 1990 | — |
| −1 | K991519 | Ameriwater Purification System for Hemodialysis | Ameriwater | 2000 | — |
| 0 (this device) | K123282 | Deonization Exchange Tanks, Carbon Exchange Tanks | Ultrapure & Industrial Services, LLC | 2013 | — |
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 14.0 · 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 |
|---|---|---|---|
| * | K991519 | Ameriwater Purification System for HemodialysisSummary page 2…in the feed water. The hydrogen and hydroxyl ions then combine to form pure water (1120). The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519. Similar to predicate meriWater, Ultra-Pure segregated aseptic exchange delonizer service in an on-line worker/polisher… | 2000 |
| † | K092481 | Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange… | 2010 |
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 23 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- 9 other devices also cite its predicate K991519.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Ultrapure & Industrial Services Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post treatment. Upon, exhaustion, these tanks will be replaced with other tanks containing…
Read the full statement (178 words)
The Ultrapure & Industrial Services Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post treatment. Upon, exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
The Ultrapure & Industrial Services Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chioramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
All Ultrapure & Industrial Services Ocionizer and Carbon Exchange Tank Service for hemodlalysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for uie In hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123282: Deonization Exchange Tanks, Carbon Exchange Tanks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123282
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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