FDA applicant
Vivos Therapeutics, Inc.
FDA records 3 decisions for Vivos Therapeutics, Inc. (Murray, KY) from 2022 to 2024: 3 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Since 2016 its 510(k)s took a median of 238 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Vivos Therapeutics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vivos Therapeutics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Vivos Therapeutics, Inc.’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 “Vivos”
FDA records each applicant name separately; these may or may not be the same firm.