Cleared Traditional

K872929 - PH MONITORING SYSTEM

K872929 is an FDA 510(k) clearance for PH MONITORING SYSTEM, manufactured by Sensatronix Medical Systems, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K872929 · Sensatronix Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
14d
Days
Class 1
Risk

K872929 is an FDA 510(k) clearance for the PH MONITORING SYSTEM. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Sensatronix Medical Systems, Inc. (So. Plainfield, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 14 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 Sensatronix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K872929

510(k) Number K872929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date August 10, 1987
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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

Devices cleared under the same product code (FFT) and FDA review panel - the closest regulatory comparables to K872929.
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