510(k) · Cleared
ClearedAcute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flier'S Quality Water Systems, Inc. · FIP Subsystem, Water Purification
Cleared on Jan 14, 2008 as substantially equivalent to K980182 (Usfilter/Ionpure, Inc., 1998) after a 270-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 14, 2008
- Review
- 270 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980182 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980182 Water Purification System for HemodialysisUsfilter/Ionpure, Inc. · 1998
- This deviceK071104 Acute Portable Exchange Deionization (Pedi) System, Central Pedi…Flier'S Quality Water Systems, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980182 | Water Purification System for Hemodialysis | Usfilter/Ionpure, Inc. | 1998 | — |
| 0 (this device) | K071104 | Acute Portable Exchange Deionization (Pedi) System, Central Pedi System… | Flier'S Quality Water Systems, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K980182 | Water Purification System for HemodialysisSummary page 1…for hemodialysis (21CFR 876.5665) Predicate Device The Flier's Quality Water Systems, Inc. systems are substantially equivalent to USFilter Corporation's/Siemens (K980182) predicate marketed water treatment systems for dialysis which use carbon and deionization canisters with pre and post filtration… | 1998 |
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.
- 6 other devices also cite its predicate K980182.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Flier's Quality Water Systems, Inc. systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001. They remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, in the reprocessing of hemodialyzers, and equipment rinse and disinfection. The Acute System #1 consists of two each carbon and mixed bed DI tanks with…
Read the full statement (284 words)
Flier's Quality Water Systems, Inc. systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001. They remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, in the reprocessing of hemodialyzers, and equipment rinse and disinfection.
The Acute System #1 consists of two each carbon and mixed bed DI tanks with pre & post filtration. It is intended to be placed on the back of dialysis machine or on a handcart for single patient dialysis. Acute System #2 consists of just carbon tanks and is intended to be used as pretreatment to a single patient RO system. The Central System #1 and #2 consists of two or more carbon and mixed bed DI tanks with pre & post filtration. They are used as either a temporary system to feed multiple dialysis machines in normal use, or for a system to feed a biomedical technician service station. For permanent, multiple station dialysis clinics Flier's recommends using central water treatment systems including reverse osmosis. The Back-up System #1 and #2 consists of two or more mixed bed DI tanks as a component in a "back up" condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions from an RO stream to meet AAMI RD62:2001 requirements. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether.
These systems are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Flier's systems are not to be used alone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071104: Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071104
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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