Not Cleared Direct

DEN210052 - Vibrant System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210052 · Vibrant, Ltd. · Gastroenterology & Urology device
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Aug 2022
Decision
269d
Days
Class 2
Risk

DEN210052 is an FDA 510(k) submission (not cleared) for the Vibrant System. Classified as Orally Ingested Transient Device For Constipation (product code QTN), Class II - Special Controls.

Submitted by Vibrant, Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on August 26, 2022 after a review of 269 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5940 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 269 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Vibrant, Ltd. devices

Submission Details

510(k) Number DEN210052 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 30, 2021
Decision Date August 26, 2022
Days to Decision 269 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 130d · This submission: 269d
Pathway characteristics

Device Classification

Product Code QTN Orally Ingested Transient Device For Constipation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5940
Definition An Orally Ingested Transient Device For Constipation Is An Electric Swallowable Capsule That Naturally Passes Through The Gastrointestinal Tract For The Treatment Of Constipation.
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.