FDA applicant
Atys
FDA records 1 decision for Atys (Soucieu En Jarrest, FR) in 2019: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). 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 Atys’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2019high 1 (2019) · low 0 (2020)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Atys’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 “Atys”
FDA records each applicant name separately; these may or may not be the same firm.