Cleared Traditional

K970674 - G.E.M. WATER SYSTEMS, INTERNATIONAL

K970674 is an FDA 510(k) clearance for G.E.M. WATER SYSTEMS, manufactured by G.E.M. Water Systems. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K970674 · G.E.M. Water Systems · Gastroenterology & Urology device
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Nov 1997
Decision
268d
Days
Class 2
Risk

K970674 is an FDA 510(k) clearance for the G.E.M. WATER SYSTEMS, INTERNATIONAL. Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by G.E.M. Water Systems (Cypress, US). The FDA issued a Cleared decision on November 19, 1997 after a review of 268 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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. Standard predicate reliance. 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 G.E.M. Water Systems devices

FDA 510(k) Submission Details - K970674

510(k) Number K970674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date November 19, 1997
Days to Decision 268 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
137d slower than avg
Panel avg: 131d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIN Device Classification - Class 2, Special Controls

Product Code FIN Tank, Holding, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FIN Tank, Holding, Dialysis

All 11
Devices cleared under the same product code (FIN) and FDA review panel - the closest regulatory comparables to K970674.
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272 · Pure Water, Inc. · Apr 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
K993058 · Pure Water, Inc. · Jan 2000
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
K992793 · Better Water, Inc. · Nov 1999
DIALYSIS MIXING & HOLDING TANK
K961416 · Dial Medical Supply · Aug 1996
NATURALYTE MIXER
K883408 · National Medical Care, Medical Products Div., Inc. · Oct 1988