Cleared Traditional

ZINETICS GASTROMETER (TM) (K862727) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K862727 · Zinetics Medical Technology Corp. · Gastroenterology & Urology device
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Nov 1986
Decision
124d
Days
Class 1
Risk

K862727 is an FDA 510(k) clearance for the ZINETICS GASTROMETER (TM). Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Zinetics Medical Technology Corp. (Salt Lake City, US). The FDA issued a Cleared decision on November 19, 1986 after a review of 124 days - within the typical 510(k) review window.

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. 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 Zinetics Medical Technology Corp. devices

Submission Details

510(k) Number K862727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1986
Decision Date November 19, 1986
Days to Decision 124 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 130d · This submission: 124d
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.