510(k) · Cleared
ClearedUPT Series Medical RO Water Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Water Technologies, Inc. · FIP Subsystem, Water Purification
Cleared on Mar 17, 2025 as substantially equivalent to K151637 (Specialty Water Technologies, 2015) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 17, 2025
- Review
- 24 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944385 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK944385 MD400 a/B/C/D/E/F/GInternational Purification Systems, Inc. · 1995
- 3 generations backK993200 MD 420/440/460/470/480/490Isopure, Corp. · 2000
- 2 generations backK051620 Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd…Better Water, Inc. · 2005
- 1 generation backK151637 UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015
- This deviceK250514 UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944385 | MD400 a/B/C/D/E/F/G | International Purification Systems, Inc. | 1995 | — |
| −3 | K993200 | MD 420/440/460/470/480/490 | Isopure, Corp. | 2000 | — |
| −2 | K051620 | Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series | Better Water, Inc. | 2005 | — |
| −1 | K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015 | — |
| 0 (this device) | K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
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 14.1 · 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? (2)
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 |
|---|---|---|---|
| * | K151637 | UPT Series Medical RO Water SystemSummary page 5…ication: 2 Product Code: FIP Predicate Devices: Primary: UPT Series Medical Reverse Osmosis Water Treatment System (151637) Additional: Isopure Complete Water Purification System (K041163) Device Description: The UPT Series Medical Reverse Osmosis Wat… | 2015 |
| * | K041163 | Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 SeriesSummary page 5…Devices: Primary: UPT Series Medical Reverse Osmosis Water Treatment System (151637) Additional: Isopure Complete Water Purification System (K041163) Device Description: The UPT Series Medical Reverse Osmosis Water Treatment System and its components consisting of; pre- treatm… | 2004 |
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 30 years and passes through 5 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove
organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for
hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment
disinfecting and rinsing.
This System is for multi patient use, such as for a dialysis clinic or hospital serving multiple patients
with a Central Water Purification System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250514 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250514: UPT Series Medical RO Water Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250514
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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