Cleared Traditional

K961346 - PH ANALYSIS MODULE (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K961346 · Synectics-Dantec · Gastroenterology & Urology device
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Jan 1997
Decision
320d
Days
Class 1
Risk

K961346 is an FDA 510(k) clearance for the PH ANALYSIS MODULE. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on January 29, 1997 after a review of 320 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: 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.

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Submission Details

510(k) Number K961346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1996
Decision Date January 29, 1997
Days to Decision 320 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 130d · This submission: 320d
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.