Cleared Traditional

K961346 - PH ANALYSIS MODULE

K961346 is an FDA 510(k) clearance for PH ANALYSIS MODULE, 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 320-day FDA review.

K961346 · Synectics-Dantec · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
320d
Days
Class 1
Risk

K961346 is an FDA 510(k) clearance for the PH ANALYSIS MODULE. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on January 29, 1997 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K961346

510(k) Number K961346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1996
Decision Date January 29, 1997
Days to Decision 320 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 131d · This submission: 320d
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 K961346.
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
K102543 · Given Imaging , Ltd. · Dec 2010
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
K013951 · Sandhill Scientific, Inc. · Feb 2002
TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
K955018 · Instrumentarium Corp. · Jan 1996
ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.
K925405 · Synectics-Dantec · Sep 1994
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
K931963 · Sandhill Scientific, Inc. · Sep 1994
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
K913817 · Synectics-Dantec · Jun 1992