Cleared Traditional

K850074 - ESOPHOGEAL PH CATHETER

K850074 is an FDA 510(k) clearance for ESOPHOGEAL PH CATHETER, manufactured by Biosearch Medical Products, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K850074 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Feb 1985
Decision
36d
Days
Class 1
Risk

K850074 is an FDA 510(k) clearance for the ESOPHOGEAL PH CATHETER. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 36 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 Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K850074

510(k) Number K850074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1985
Decision Date February 14, 1985
Days to Decision 36 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
95d faster than avg
Panel avg: 131d · This submission: 36d
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 19
Devices cleared under the same product code (FFT) and FDA review panel - the closest regulatory comparables to K850074.
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
PROXIMA 1 PH MONITOR
K841384 · American Endoscopy, Inc. · Jul 1984
MODEL 700 GASTROREFLUX MONITOR/AMALYZER
K822815 · Del Mar Avionics · Oct 1982