Cleared Traditional

K232830 - Vibrant System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K232830 · Vibrant, Ltd. · Gastroenterology & Urology device
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Dec 2023
Decision
86d
Days
Class 2
Risk

K232830 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 December 8, 2023 after a review of 86 days - a notably fast clearance cycle.

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: 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 Vibrant, Ltd. devices

Submission Details

510(k) Number K232830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2023
Decision Date December 08, 2023
Days to Decision 86 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: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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.

Clinical Evidence

ClinicalTrials.gov
NCT05036369 Completed Interventional Industry-sponsored

Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation

100
Patients (actual)
2
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Constipation Chronic Idiopathic
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Tal Malina, MBA
Sponsor Vibrant Ltd. (industry)
Started 2021-07-05 → Primary completion 2022-12-15
Primary outcome
CSBM 1 Success Rate
Secondary outcome
Straining Based on the Subject's Assessment Recorded in Daily Diaries
View full study on ClinicalTrials.gov