Cleared Traditional

K853280 - FOUR CHANNEL PH PROBE

K853280 is an FDA 510(k) clearance for FOUR CHANNEL PH PROBE, manufactured by Akron City Hospital. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K853280 · Akron City Hospital · Gastroenterology & Urology device
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Dec 1985
Decision
119d
Days
Class 1
Risk

K853280 is an FDA 510(k) clearance for the FOUR CHANNEL PH PROBE. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Akron City Hospital (Akron, US). The FDA issued a Cleared decision on December 2, 1985 after a review of 119 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.

FDA 510(k) Submission Details - K853280

510(k) Number K853280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date December 02, 1985
Days to Decision 119 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
12d faster than avg
Panel avg: 131d · This submission: 119d
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 23
Devices cleared under the same product code (FFT) and FDA review panel - the closest regulatory comparables to K853280.
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 LIBERTY SYS COMPRIS DIGITRAPPER MK II MO
K853648 · Synectics-Dantec · Nov 1985
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
K850361 · Synectics-Dantec · May 1985
ESOPHOGEAL PH CATHETER
K850074 · Biosearch Medical Products, Inc. · Feb 1985