Cleared Traditional

K853280 - FOUR CHANNEL PH PROBE

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

K853280 · Akron City Hospital · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Akron City Hospital devices

Submission Details

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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (FFT) and FDA review panel - the closest regulatory comparables to K853280.
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
K102543 · Given Imaging , Ltd. · Dec 2010
MODEL 1010 AMBULATORY PH MONITORING SYSTEM
K862536 · Oxford Medilog, Inc. · Sep 1986
AMBI-24 PH/PRESSURE MONITOR
K854514 · Biosearch Medical Products, Inc. · Feb 1986
ESOPHOGEAL PH CATHETER
K850074 · Biosearch Medical Products, Inc. · Feb 1985
MODEL 700 GASTROREFLUX MONITOR/AMALYZER
K822815 · Del Mar Avionics · Oct 1982