Cleared Traditional

REVERSE OSMOSIS SYSTEM (K944493) - FDA 510(k) Clearance

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

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

Submission Details

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
Regulatory Context
Review time vs. panel average
395d slower than avg
Panel avg: 130d · This submission: 525d
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.

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