Cleared Traditional

PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST (K964539) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964539 · Zyzatech Water Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
379d
Days
Class 2
Risk

K964539 is an FDA 510(k) clearance for the PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF,.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Zyzatech Water Systems, Inc. (Kent, US). The FDA issued a Cleared decision on November 26, 1997 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zyzatech Water Systems, Inc. devices

Submission Details

510(k) Number K964539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date November 26, 1997
Days to Decision 379 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 130d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIP Subsystem, Water Purification

All 116
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K964539.
AquaC UNO H
K250471 · Fresenius Medical Care Renal Therapies Group, LLC · Nov 2025
DIASAFEplusUS (F00013010)
K251851 · Fresenius Medical Care Renal Therapies Group, LLC · Oct 2025
AquaA
K252181 · Fresenius Medical Care North America · Sep 2025
UPT Series Medical RO Water Treatment System
K250514 · Specialty Water Technologies, Inc. · Mar 2025
AquaBplus
K232953 · Fresenius Medical Care Renal Therapies Group, LLC · Jun 2024
AQUAbase nX
K223479 · B.Braun Medical, Inc. · Aug 2023