510(k) · Cleared
ClearedVibrant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vibrant, Ltd. · QTN Orally Ingested Transient Device For Constipation
Cleared on Dec 8, 2023 as substantially equivalent to K223031 (Vibrant, Ltd., 2023) after an 86-day review. Its family tree reaches back 2 generations to 2022.
- Decided
- Dec 8, 2023
- Review
- 86 days
- Class
- Class II
- Product code
- QTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN210052 (2022). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QTN device
- #1 K223031 Vibrant Systemscore 7.7 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K223031 | Vibrant SystemSummary page 5…Ingested Transient Device For Constipation Regulation Number: 21 CFR 876.5940 Regulatory Class: II Product Code: QTN Predicate Device Vibrant Ltd.’s Vibrant System (K223031) A. Device Description The Vibrant System is designed to mechanically induce peristaltic activity in the colon, th… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 11 months on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QTN devicesQTN Orally Ingested Transient Device For Constipation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QTN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QTN
Too few QTN 510(k)s in any year since 2007 to give a median.
Recalls per year · QTN
No recall names QTN since 2007.
Adverse event reports per year · QTN
4in 2025
MAUDE reports naming product code QTN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232830: Vibrant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232830
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026