Cleared Traditional

K964539 - PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST

K964539 is an FDA 510(k) clearance for PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, manufactured by Zyzatech Water Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 379-day FDA review.

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

FDA 510(k) Submission Details - K964539

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 131d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K964539.
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K974899 · Gambro Healthcare · Sep 1998
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · Gambro Healthcare · May 1998
HYDRA METER
K974127 · Automata Instrumentation, Inc. · Dec 1997
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
K945559 · Mar Cor Services, Inc. · May 1996
REVERSE OSMOSIS SYSTEM
K944493 · G.E.M. Water Systems · Feb 1996
PORTABLE REVERSE OSMOSIS MACHINE
K954928 · Better Water, Inc. · Jan 1996