Cleared Traditional

SMARTPILL GI MONITORING SYSTEM (K053547) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053547 · The Smartpill Corporation · Gastroenterology & Urology device
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Jul 2006
Decision
210d
Days
Class 2
Risk

K053547 is an FDA 510(k) clearance for the SMARTPILL GI MONITORING SYSTEM. Classified as Gastrointestinal Motility System, Capsule (product code NYV), Class II - Special Controls.

Submitted by The Smartpill Corporation (Buffalo, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 210 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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.

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Submission Details

510(k) Number K053547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date July 18, 2006
Days to Decision 210 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
80d slower than avg
Panel avg: 130d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NYV Gastrointestinal Motility System, Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
Definition Used To Evaluate Gi Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.