Cleared Traditional

K092342 - SMARTPILL GI MONITORING SYSTEM, VERSION 2.0

K092342 is an FDA 510(k) clearance for SMARTPILL GI MONITORING SYSTEM, manufactured by The Smartpill Corporation. The device is a Class 2 Gastroenterology & Urology device with product code NYV cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K092342 · The Smartpill Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
87d
Days
Class 2
Risk

K092342 is an FDA 510(k) clearance for the SMARTPILL GI MONITORING SYSTEM, VERSION 2.0. 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 October 30, 2009 after a review of 87 days - a notably fast clearance 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: 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 The Smartpill Corporation devices

FDA 510(k) Submission Details - K092342

510(k) Number K092342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date October 30, 2009
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

NYV Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00603707 Completed Observational Industry-sponsored

Assessment of Whole Gut Transit Time Using the SmartPill Capsule

Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study

178
Patients (actual)
8
Sites
Condition studied Constipation
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Henry Parkman, MD
Sponsor The SmartPill Corporation (industry)
Started 2006-10-01 → Primary completion 2008-06-01
Primary outcome
whole gut transit time
Secondary outcome
Determine regional gut (gastric, small bowel, colonic) transit times
Study completed - no results published. This trial concluded in 2008 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov