510(k) · Cleared

Cleared

Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst

K964539510(k) TraditionalCleared Nov 26, 1997379-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

Zyzatech Water Systems, Inc. · FIP Subsystem, Water Purification

Cleared on Nov 26, 1997 after a 379-day review. The FDA summary names its predicate without a number. 29 later devices descend from it.

Decided: Nov 26, 1997
Review: 379 days
Class: Class II
Product code: FIP
Recalls: None
Predicates: 0

29 later devices descend from it, 8 citing it directly.

This deviceK964539 Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704…Zyzatech Water Systems, Inc. · 1997
Descendant · cites it directly · 12 of its ownK010131 PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…Aksys, Ltd. · 2002 · Recalled
Descendant · cites it directly · 6 of its ownK110578 Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · Recalled
Descendant · 2 generations on · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
Descendant · 2 generations on · 5 of its ownK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
Descendant · 3 generations on · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2000high 4 (2000) · low 0 (2001)2026

Most influential descendants

Showing 5 of 29 · See all

K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd. · 2002 · cites it directly12descendants
K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · cites it directly6descendants
K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · 2 generations on5descendants
K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005 · 2 generations on5descendants
K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964539	Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF…	Zyzatech Water Systems, Inc.	1997	—
+1	K010131	PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…	Aksys, Ltd.	2002	1
+1	K110578	Millenium HX Portable Reverse Osmosis Water Purification System	Mar Cor Purification, Inc.	2011	1
+2	K112314	Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter	Nephros, Inc.	2012	—
+2	K043436	Nxstage Dialysate Preparation Module, Model NX0269	Nxstage Medical, Inc.	2005	—
+3	K060296	Nxstage Dialysate Preparation Module	Nxstage Medical, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	4	0
2002	1	0
2003	2	0
2005	1	0
2006	1	0
2008	2	0
2011	2	0
2012	4	0
2014	2	0
2015	1	0
2018	1	0
2019	1	0
2020	1	0
2022	1	0
2024	2	0
2025	3	0

FIG. 1 — Lineage of K964539, 1997–2025Source: 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 14.0 · 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? (3)

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	Recalls
*	—	Water Purification System manufactured by Better Water Inc. Named without a submission number	—
*	—	HD-100 Hemodialysis Systems & Accessories manufactured by Water Pure Corporation Named without a submission number	—
*	—	Hemo-RO/Milli RO Water Purification Systems manufactured by Millipore Corporation Named without a submission number	—

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K010131	PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…	Aksys, Ltd.	2002	12
K110578	Millenium HX Portable Reverse Osmosis Water Purification System	Mar Cor Purification, Inc.	2011	6
K030348	Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO…	Biolab Equipment Canada, Ltd.	2003	2
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
K021560	Modification to Ameriwater Purification System for Hemodialysis	Ameriwater	2003	0
K993877	Nelson Water Systems for Hemodialysis	Nelson Environmental Technologies, Inc.	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, K010131 (Aksys, Ltd., 2002) has gone furthest, with 12 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?

A ZyzaTech Portable, V| Z or T Series Reverse Osmosis System and its pretreatment and product water distribution components is intended for use with a hemodialysis system to remove organic and 1norganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and 1o produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964539 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964539: Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964539

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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