# K964539: Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst

- Pathway: 510(k) (Traditional)
- Applicant: Zyzatech Water Systems, Inc.
- Decided: Nov 26, 1997 after 379 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 8 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Water Purification System manufactured by Better Water Inc.: named in the summary without a submission number
- (no number) HD-100 Hemodialysis Systems & Accessories manufactured by Water Pure Corporation: named in the summary without a submission number
- (no number) Hemo-RO/Milli RO Water Purification Systems manufactured by Millipore Corporation: named in the summary without a submission number

## Most influential descendants
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), 12 descendants of its own
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System (2011), 6 descendants of its own
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K043436: Nxstage Dialysate Preparation Module, Model NX0269 (2005), 5 descendants of its own
- K060296: Nxstage Dialysate Preparation Module (2006), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K964539
Methodology: https://510kreport.com/methodology