FDA applicant
Vibrant, Ltd.
FDA records 3 decisions for Vibrant, Ltd. (Yokneam, IL) from 2022 to 2023: 2 510(k) clearances and 1 De Novo grant. All are in product code QTN (Orally Ingested Transient Device For…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vibrant, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Vibrant, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Vibrant”
FDA records each applicant name separately; these may or may not be the same firm.