510(k) · Cleared

Cleared

Water Purification System for Hemodialysis

K920186510(k) TraditionalCleared Jun 13, 19951,246-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

Better Water, Inc. · FIP Subsystem, Water Purification

Cleared on Jun 13, 1995 after a 1,246-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided: Jun 13, 1995
Review: 1,246 days
Class: Class II
Product code: FIP
Recalls: None
Predicates: 0

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

This deviceK920186 Water Purification System for HemodialysisBetter Water, Inc. · 1995
Descendant · cites it directly · 3 of its ownK051620 Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd…Better Water, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK151637 UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015
Descendant · cites it directly · 1 of its ownK033648 Performance Water Treatment SystemPerformance Water Systems, LLC · 2004
Descendant · cites it directly · 1 of its ownK993272 Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemPure Water, Inc. · 2000 · Recalled
Descendant · cites it directly · 1 of its ownK993058 Pure Water Inc's Acidified Storage and Distribution System with…Pure Water, Inc. · 2000

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1998high 5 (2000) · low 0 (1999)2026

Most influential descendants

Showing 5 of 15 · See all

K051620Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd SeriesBetter Water, Inc. · 2005 · cites it directly3descendants
K151637UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015 · 2 generations on1descendant
K033648Performance Water Treatment SystemPerformance Water Systems, LLC · 2004 · cites it directly1descendant
K993272Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemPure Water, Inc. · 2000 · cites it directly1descendant
K993058Pure Water Inc's Acidified Storage and Distribution System with Optional Remote FillPure Water, Inc. · 2000 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920186	Water Purification System for Hemodialysis	Better Water, Inc.	1995	—
+1	K051620	Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series	Better Water, Inc.	2005	—
+2	K151637	UPT Series Medical RO Water System	Specialty Water Technologies	2015	—
+1	K033648	Performance Water Treatment System	Performance Water Systems, LLC	2004	—
+1	K993272	Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System	Pure Water, Inc.	2000	1
+1	K993058	Pure Water Inc's Acidified Storage and Distribution System with Optional…	Pure Water, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	5	0
2004	1	0
2005	2	0
2012	3	0
2015	1	0
2016	1	0
2025	1	0

FIG. 1 — Lineage of K920186, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K051620	Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series	Better Water, Inc.	2005	3
K033648	Performance Water Treatment System	Performance Water Systems, LLC	2004	1
K993272	Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System	Pure Water, Inc.	2000	1
K993058	Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill	Pure Water, Inc.	2000	1
K981680	Ultrapure Water Treatment System for Hemodialysis	Dayton Water Systems	1998	1
K161844	Matrix Pre-Treatment Controller	Better Water, LLC	2016	0
K043344	Dialysis Services Water Treatment & Distribution System	Dialysis Services, Inc.	2005	0
K993520	H20NLY Complete Water Purification System for Hemodialysis	Serv-A-Pure Co.	2000	0
K992786	Pure Water, Inc.'S Water Purification Systems	Pure Water, Inc.	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, K051620 (Better Water, Inc., 2005) has gone furthest, with 3 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	—

https://510kreport.com/device/K920186 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920186: Water Purification System for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920186

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026