# K232830: Vibrant System

- Pathway: 510(k) (Traditional)
- Applicant: Vibrant, Ltd.
- Decided: Dec 8, 2023 after 86 days
- Product code: QTN (Orally Ingested Transient Device For Constipation)
- Device class: 2
- Regulation: 21 CFR 876.5940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN210052 (2022). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223031: Vibrant System, Vibrant, Ltd. (2023) Summary page 5.

## Indications for use
The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

Source page: https://510kreport.com/device/K232830
Methodology: https://510kreport.com/methodology