FDA applicant
Scientific Intake
FDA records 2 decisions for Scientific Intake (Lawrence, MA) from 2016 to 2017: 1 510(k) clearance and 1 De Novo grant. All are in product code ONY (Oral Removable Retainer For Weight Management). Its devices cite 1 predicate, 1 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 Scientific Intake’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Scientific Intake’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) Report