Cleared Traditional

K944493 - REVERSE OSMOSIS SYSTEM

K944493 is an FDA 510(k) clearance for REVERSE OSMOSIS SYSTEM, manufactured by G.E.M. Water Systems. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 525-day FDA review.

K944493 · G.E.M. Water Systems · Gastroenterology & Urology device
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Feb 1996
Decision
525d
Days
Class 2
Risk

K944493 is an FDA 510(k) clearance for the REVERSE OSMOSIS SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by G.E.M. Water Systems (Cypress, US). The FDA issued a Cleared decision on February 20, 1996 after a review of 525 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all G.E.M. Water Systems devices

FDA 510(k) Submission Details - K944493

510(k) Number K944493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date February 20, 1996
Days to Decision 525 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
394d slower than avg
Panel avg: 131d · This submission: 525d
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 K944493.
HYDRA METER
K974127 · Automata Instrumentation, Inc. · Dec 1997
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
K964539 · Zyzatech Water Systems, Inc. · Nov 1997
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
K945559 · Mar Cor Services, Inc. · May 1996
PORTABLE REVERSE OSMOSIS MACHINE
K954928 · Better Water, Inc. · Jan 1996
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995