Cleared Traditional

K853648 - SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO

K853648 is an FDA 510(k) clearance for SYNECTICS LIBERTY SYS COMPRIS DIGITRAPP..., 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 76-day FDA review.

K853648 · Synectics-Dantec · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
76d
Days
Class 1
Risk

K853648 is an FDA 510(k) clearance for the SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO. 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 November 18, 1985 after a review of 76 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 - K853648

510(k) Number K853648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date November 18, 1985
Days to Decision 76 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
55d faster than avg
Panel avg: 131d · This submission: 76d
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 K853648.
SYNECTICS MOTILITY SYSTEM
K862929 · Synectics-Dantec · Oct 1986
MODEL 1010 AMBULATORY PH MONITORING SYSTEM
K862536 · Oxford Medilog, Inc. · Sep 1986
AMBI-24 PH/PRESSURE MONITOR
K854514 · Biosearch Medical Products, Inc. · Feb 1986
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
K850361 · Synectics-Dantec · May 1985
ESOPHOGEAL PH CATHETER
K850074 · Biosearch Medical Products, Inc. · Feb 1985
PROXIMA 1 PH MONITOR
K841384 · American Endoscopy, Inc. · Jul 1984