Vibrant, Ltd.: FDA clearances and approvals
Vibrant, Ltd. has 2 FDA 510(k) clearances (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 96 days. It is the industry lead sponsor of 8 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 2 | 96 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Vibrant, Ltd.'s cleared 510(k)s took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QTN | Orally Ingested Transient Device For Constipation | 3 | 2 |
Review panels
Most recent Vibrant, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232830 | Vibrant System | QTN | 2023-12-08 | 86 |
| K223031 | Vibrant System | QTN | 2023-01-13 | 106 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210052 | De Novo | Orally Ingested Transient Device For Constipation | 2022-08-26 |
Recalls
openFDA lists no recalls under a recalling firm named Vibrant, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Vibrant, Ltd. is the industry lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05036369: Vibrant Capsule vs. Placebo for Patient Suffering From Constipation (Completed, started 2021-07-05)
- NCT03879239: Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Completed, started 2019-04-08)
- NCT04458675: Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC) (Completed, started 2018-07-26)
- NCT03329027: A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes (Completed, started 2017-11-14)
- NCT03031301: A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week (Completed, started 2017-02-01)
Frequently asked questions
How many FDA 510(k) clearances does Vibrant, Ltd. have?
Vibrant, Ltd. has 2 FDA 510(k) clearances (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Vibrant, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Vibrant, Ltd.'s cleared 510(k)s is 96 days.
What devices does Vibrant, Ltd. make?
Its most frequent FDA product codes are QTN (Orally Ingested Transient Device For Constipation, 3).
Has Vibrant, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vibrant, Ltd. Related entities may recall under other names.
Next steps
- See all 2 Vibrant, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QTN, Vibrant, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.