Cleared Traditional

K850361 - SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E

K850361 is an FDA 510(k) clearance for SYNECTICS PH SYS COMPRISING DIGITRAPPER..., 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 91-day FDA review.

K850361 · Synectics-Dantec · Gastroenterology & Urology device
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May 1985
Decision
91d
Days
Class 1
Risk

K850361 is an FDA 510(k) clearance for the SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Synectics-Dantec (Chicago, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 91 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 Synectics-Dantec devices

FDA 510(k) Submission Details - K850361

510(k) Number K850361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date May 01, 1985
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
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 K850361.
MODEL 1010 AMBULATORY PH MONITORING SYSTEM
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SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO
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K850074 · Biosearch Medical Products, Inc. · Feb 1985
PROXIMA 1 PH MONITOR
K841384 · American Endoscopy, Inc. · Jul 1984
MODEL 700 GASTROREFLUX MONITOR/AMALYZER
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