510(k) · Cleared
ClearedMED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Tech Water Systems, Inc. · FIP Subsystem, Water Purification
Cleared on Aug 4, 2016 as substantially equivalent to K944493 (G.E.M. Water Systems, 1996) after a 259-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 4, 2016
- Review
- 259 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944493 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK944493 Reverse Osmosis SystemG.E.M. Water Systems · 1996
- This deviceK153329 MED-TECH Water Systems Inc Exchangeable Carbon Tanks for DialysisMed-Tech Water Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944493 | Reverse Osmosis System | G.E.M. Water Systems | 1996 | — |
| 0 (this device) | K153329 | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | Med-Tech Water Systems, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K944493 | Reverse Osmosis SystemSummary page 4…I Medical Device under §876.5665 Panel: Gastroenterology Product Code: FIP Equivalent Device: K944493 G.E.M. Water Systems REVERSE OSMOSIS SYSTEM Device Description: MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialys… | 1996 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K944493.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
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/K153329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153329: MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153329
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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