510(k) · Cleared

Cleared

Water Purification System for Hemodialysis

K980182510(k) TraditionalCleared Nov 16, 1998300-day reviewClass II21 CFR 876.5665

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Usfilter/Ionpure, Inc. · FIP Subsystem, Water Purification

Cleared on Nov 16, 1998 after a 300-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided: Nov 16, 1998
Review: 300 days
Class: Class II
Product code: FIP
Recalls: None
Predicates: 0

9 later devices descend from it, 7 citing it directly.

This deviceK980182 Water Purification System for HemodialysisUsfilter/Ionpure, Inc. · 1998
Descendant · cites it directly · 2 of its ownK030348 Biopure Portable RO System,Biopure 4400 Series RO System, Biopure…Biolab Equipment Canada, Ltd. · 2003
Descendant · 2 generations on · 0 of its ownK133149 Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK112331 Biopure Portable RO SystemsArion Water, Inc. · 2012
Descendant · cites it directly · 0 of its ownK080703 Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon…4m Ventures, Inc. · 2008
Descendant · cites it directly · 0 of its ownK071104 Acute Portable Exchange Deionization (Pedi) System, Central Pedi…Flier'S Quality Water Systems, Inc. · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2000high 2 (2005) · low 0 (2001)2026

Most influential descendants

Showing 5 of 9 · See all

K030348Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO…Biolab Equipment Canada, Ltd. · 2003 · cites it directly2descendants
K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2014 · 2 generations on0descendants
K112331Biopure Portable RO SystemsArion Water, Inc. · 2012 · 2 generations on0descendants
K080703Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank4m Ventures, Inc. · 2008 · cites it directly0descendants
K071104Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi…Flier'S Quality Water Systems, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K980182	Water Purification System for Hemodialysis	Usfilter/Ionpure, Inc.	1998	—
+1	K030348	Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series…	Biolab Equipment Canada, Ltd.	2003	—
+2	K133149	Biopure HX2 Reverse Osmosis Water Purification System	Mar Cor Purification, Inc.	2014	—
+2	K112331	Biopure Portable RO Systems	Arion Water, Inc.	2012	—
+1	K080703	Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank	4m Ventures, Inc.	2008	—
+1	K071104	Acute Portable Exchange Deionization (Pedi) System, Central Pedi System…	Flier'S Quality Water Systems, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2003	1	0
2005	2	0
2008	2	0
2012	1	0
2014	1	0

FIG. 1 — Lineage of K980182, 1998–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030348	Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO…	Biolab Equipment Canada, Ltd.	2003	2
K080703	Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank	4m Ventures, Inc.	2008	0
K071104	Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi…	Flier'S Quality Water Systems, Inc.	2008	0
K042018	Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi…	Simply Clean Air & Water, Inc.	2005	0
K041884	Mueller Water Conditioning Water Purification System for Hemodialysis	Mueller Water Conditioning, Inc.	2005	0
K014169	Water Purification Components for Hemodialysis	Bob J. Johnson & Assoc., Inc.	2002	0
K993520	H20NLY Complete Water Purification System for Hemodialysis	Serv-A-Pure Co.	2000	0

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?

Of its descendants, K030348 (Biolab Equipment Canada, Ltd., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FIP devices

FIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIP

4in 2025

2007high 4 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIP

88in 2025

2007high 202 (2008) · low 69 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FIP

1in 2020

2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FIP

77in 2025

2007high 174 (2024) · low 0 (2009)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 USFilter water purification systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate and to produce dialysis water and purified water for purposes such as dialyzer reprocessing and final rinse and disinfection.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980182: Water Purification System for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980182

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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