510(k) · Cleared

Cleared

NX Stage Water Purification System

K042089510(k) TraditionalCleared Nov 24, 2004113-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

Nxstage Medical, Inc. · FIP Subsystem, Water Purification

Cleared on Nov 24, 2004 as substantially equivalent to K030059 (Ameriwater, 2003) and 3 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1987.

Decided: Nov 24, 2004
Review: 113 days
Class: Class II
Product code: FIP
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K873487 (1987). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK873487 HD-400-a/B/C Hemodialysis Systems & AccessoriesWater Pure, Inc. · 1987
2 generations backK945559 Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996
1 generation backK994292 Water Purification SystemWater & Power Technologies, Inc. · 2001
This deviceK042089 NX Stage Water Purification SystemNxstage Medical, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K873487	HD-400-a/B/C Hemodialysis Systems & Accessories	Water Pure, Inc.	1987	—
−2	K945559	Mar Cor Complete Water Treatment System for Kdney Dialysis	Mar Cor Services, Inc.	1996	—
−1	K994292	Water Purification System	Water & Power Technologies, Inc.	2001	—
0 (this device)	K042089	NX Stage Water Purification System	Nxstage Medical, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1995	1	0
2001	1	0
2003	2	0

FIG. 1 — Lineage of K042089, 1987–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 14.1 · 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? (4)

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	Applicant	Decided	Recalls
*	K030059	Portable RO+ Model MROS09 Summary page 1 …System is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA: * AmeniWater Portable RO+ Model MROSOO, (K030059, cleared 04/07/03) * HydroPure Deionization Systems, (K022747, cleared 02/11/03) * Water & Power Technologies o…	Ameriwater	2003	—
*	K022747	Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi System Summary page 1 …ed predicate devices previously cleared by FDA: * AmeniWater Portable RO+ Model MROSOO, (K030059, cleared 04/07/03) * HydroPure Deionization Systems, (K022747, cleared 02/11/03) * Water & Power Technologies of Texas, Inc. (K994292, cleared 01/02/01) * Total Water Treatm…	Hydropure Systems, Inc.	2003	—
*	K994292	Water Purification System Summary page 1 …O+ Model MROSOO, (K030059, cleared 04/07/03) * HydroPure Deionization Systems, (K022747, cleared 02/11/03) * Water & Power Technologies of Texas, Inc. (K994292, cleared 01/02/01) * Total Water Treatment System, (K002045, cleared 02/16/01) Traditional 510(k) Confidential…	Water & Power Technologies, Inc.	2001	—
*	K002045	Water Purification System for Hemodialysis Summary page 1 …onization Systems, (K022747, cleared 02/11/03) * Water & Power Technologies of Texas, Inc. (K994292, cleared 01/02/01) * Total Water Treatment System, (K002045, cleared 02/16/01) Traditional 510(k) Confidential…	Total Water Treatment Systems, Inc.	2001	—

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?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
None of the 8 ancestors has a recall.

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 NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042089 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042089: NX Stage Water Purification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042089

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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