Cleared Traditional

K002028 - BRAVO PH MONITORING SYSTEM

K002028 is an FDA 510(k) clearance for BRAVO PH MONITORING SYSTEM, manufactured by Endonetics, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K002028 · Endonetics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
88d
Days
Class 1
Risk

K002028 is an FDA 510(k) clearance for the BRAVO PH MONITORING SYSTEM. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Endonetics, Inc. (Los Gatos, US). The FDA issued a Cleared decision on September 29, 2000 after a review of 88 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 Endonetics, Inc. devices

FDA 510(k) Submission Details - K002028

510(k) Number K002028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date September 29, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
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 K002028.
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