Cleared Traditional

TONOMITOR(TM) (K870606) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K870606 · Tonometrics Holdings SA C/O Mackeen Consultants · Gastroenterology & Urology device
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Apr 1987
Decision
58d
Days
Class 1
Risk

K870606 is an FDA 510(k) clearance for the TONOMITOR(TM). Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Tonometrics Holdings SA C/O Mackeen Consultants (Bethesda, US). The FDA issued a Cleared decision on April 10, 1987 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tonometrics Holdings SA C/O Mackeen Consultants devices

Submission Details

510(k) Number K870606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1987
Decision Date April 10, 1987
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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.