Cleared Traditional

LOT 440 (K950087) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K950087 · Medical Instruments Corporation Mic AG · Gastroenterology & Urology device
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Feb 1996
Decision
392d
Days
Class 1
Risk

K950087 is an FDA 510(k) clearance for the LOT 440. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Medical Instruments Corporation Mic AG (Solothurn, CH). The FDA issued a Cleared decision on February 6, 1996 after a review of 392 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.

View all Medical Instruments Corporation Mic AG devices

Submission Details

510(k) Number K950087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date February 06, 1996
Days to Decision 392 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
262d slower than avg
Panel avg: 130d · This submission: 392d
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.