Cleared Traditional

K925405 - ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K925405 · Synectics-Dantec · Gastroenterology & Urology device
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Sep 1994
Decision
704d
Days
Class 1
Risk

K925405 is an FDA 510(k) clearance for the ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 704 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1400 - 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.

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Submission Details

510(k) Number K925405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1992
Decision Date September 30, 1994
Days to Decision 704 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
574d slower than avg
Panel avg: 130d · This submission: 704d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFT Electrode, Ph, Stomach
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.