510(k) · Cleared
ClearedFluid Process Systems Exchange Carbon and Deionization Tanks for Use in Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluid Process Systems, Inc. · FIP Subsystem, Water Purification
Cleared on Aug 28, 2000 after a 488-day review. The FDA summary names no predicate by number.
- Decided
- Aug 28, 2000
- Review
- 488 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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 | — |
What is it indicated for?
The intended use of this system, comprising of the following components, is to provide water to dilute dialysate for use in HEMODIALYSIS applications., Carbon Tank (see description inside the application) Cation Deionization Tank Anion Deionization Tank Mixed Bed Deionization Tank Mixed Bed Deionization Tank (used as a polisher tank) The combination of the above listed components will deliver water which exceeds AAMI Standards for water used to dilute…
Read the full statement (177 words)
The intended use of this system, comprising of the following components, is to provide water to dilute dialysate for use in HEMODIALYSIS applications.,
Carbon Tank (see description inside the application)
Cation Deionization Tank
Anion Deionization Tank
Mixed Bed Deionization Tank
Mixed Bed Deionization Tank (used as a polisher tank)
The combination of the above listed components will deliver water which exceeds AAMI Standards for water used to dilute dialysate for HEMODIALYSIS. The system does not come into contact with any patient and is used solely as indicated. The components are used in this serles (without exception) and are ‘ not designed to be bypassed at any paint. The process requires additional components which are added qr fumished by the end user. These include an LTRAVIOLET DISINFECTION-SSlls al‘and an ULTRAFILTER, with a rating of -05 micron, to reduced the risk of pyrogens being passed through the system. The instruction manual outlines several tests which are required prior to use prior to every patient shift. The final decision to use the water for HEMODIALYSIS rests with the medical director.
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/K991495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991495: Fluid Process Systems Exchange Carbon and Deionization Tanks for Use in Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991495
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026