Cleared Traditional

K223031 - Vibrant System (FDA 510(k) Clearance)

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

K223031 · Vibrant, Ltd. · Gastroenterology & Urology device
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Jan 2023
Decision
106d
Days
Class 2
Risk

K223031 is an FDA 510(k) clearance 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 Cleared decision on January 13, 2023 after a review of 106 days - within the typical 510(k) review window.

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 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.

View all Vibrant, Ltd. devices

Submission Details

510(k) Number K223031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date January 13, 2023
Days to Decision 106 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
24d faster than avg
Panel avg: 130d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.