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
Simply Clean Air & Water, Inc. · FIP Subsystem, Water Purification
Cleared on Apr 15, 2005 as substantially equivalent to K980182 (Usfilter/Ionpure, Inc., 1998) after a 262-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 15, 2005
- Review
- 262 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 deviceK042018 Acute Portable Exchange Deionization (Pedi) System, Central Pedi…Simply Clean Air & Water, Inc. · 2005
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) | K042018 | Acute Portable Exchange Deionization (Pedi) System, Central Pedi System… | Simply Clean Air & Water, Inc. | 2005 | — |
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…cation systems for hemodialysis (21CFR 876.5665) Predicate Device The Simply Clean Air & Water PEDI Systems are substantially equivalent to US Filter Corporation's (K980182) predicate marketed water treatment systems for dialysis which use carbon and deionization canisters with pre and post filtratio… | 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.
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?
Systems are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers, equipment rinse and disinfection. The Acute PEDI System consists of a sediment filter, carbon filtration, mixed bed deionizers, endotoxin filter and system monitoring with remote alarm functions. It is intended for use in a location…
Read the full statement (197 words)
Systems are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers, equipment rinse and disinfection.
The Acute PEDI System consists of a sediment filter, carbon filtration, mixed bed deionizers, endotoxin filter and system monitoring with remote alarm functions. It is intended for use in a location with a portable dialysis machine for the dialysis of a single patient.
The Central PEDI System consists of a booster pump / pressure tank assembly, sediment filter, carbon filtration, mixed bed deionizers, resin trap filter, endotoxin filter and system monitoring with flow isolation/divert and remote alarm functions. It is intended for use in a central location for the dialysis of multiple patients.
The Back-up PEDI System consists of mixed bed deionizers, intermediate water quality (QC) indicator (light) and connection hoses. It is intended for use to provide a "back-up" for reverse osmosis unit repair or to "polish" the product outlet of a RO to meet AAMI RD62:2001 requirements. Endotoxin filtration and system monitoring with flow isolation / divert and remote alarm functions are provided when required to meet ANSI/AAMI RD62:2001 requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042018: 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/K042018
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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