Cleared Traditional

K102543 - BRAVO PH MONITORING SYSTEM AND ACCESSORIES (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K102543 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2010
Decision
89d
Days
Class 1
Risk

K102543 is an FDA 510(k) clearance for the BRAVO PH MONITORING SYSTEM AND ACCESSORIES. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on December 1, 2010 after a review of 89 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 Given Imaging , Ltd. devices

Submission Details

510(k) Number K102543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date December 01, 2010
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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.