FDA applicant
Hinlab Sas
FDA records 2 decisions for Hinlab Sas (Neuilly Sur Seine, FR) from 2023 to 2024: 2 510(k) clearances. Most are in product codes MSX (System, Network And Communication…) and DQA (Oximeter). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Hinlab, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hinlab Sas’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 2023.
Planning a device like Hinlab Sas’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