Cleared Traditional

PROXIMA 1 PH MONITOR (K881706) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K881706 · Technomanagement, Inc. C/O C.G. · Gastroenterology & Urology device
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Jul 1988
Decision
84d
Days
Class 1
Risk

K881706 is an FDA 510(k) clearance for the PROXIMA 1 PH MONITOR. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Technomanagement, Inc. C/O C.G. (Findley, US). The FDA issued a Cleared decision on July 12, 1988 after a review of 84 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 Technomanagement, Inc. C/O C.G. devices

Submission Details

510(k) Number K881706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date July 12, 1988
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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.