Cleared Traditional

K902366 - MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT

K902366 is an FDA 510(k) clearance for MODIFIED PROXIMA MONITOR/DIGITRAPPER ED..., manufactured by Synectics-Dantec. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K902366 · Synectics-Dantec · Gastroenterology & Urology device
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Jun 1990
Decision
23d
Days
Class 1
Risk

K902366 is an FDA 510(k) clearance for the MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 23 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 Synectics-Dantec devices

FDA 510(k) Submission Details - K902366

510(k) Number K902366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date June 08, 1990
Days to Decision 23 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 131d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

FFT Device Classification - Class 1, General Controls

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.

Regulatory Peers - FFT Electrode, Ph, Stomach

All 18
Devices cleared under the same product code (FFT) and FDA review panel - the closest regulatory comparables to K902366.
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
K913817 · Synectics-Dantec · Jun 1992
PH METER, MODIFICATION
K914624 · Synectics-Dantec · Apr 1992
DIGITRAPPER MARK III
K913387 · Synectics-Dantec · Dec 1991
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE
K871282 · Synectics-Dantec · Jun 1987
SYNECTICS MOTILITY SYSTEM
K862929 · Synectics-Dantec · Oct 1986
MODEL 1010 AMBULATORY PH MONITORING SYSTEM
K862536 · Oxford Medilog, Inc. · Sep 1986