FDA applicant
Atmo Biosciences, Ltd.
FDA records 2 decisions for Atmo Biosciences, Ltd. (Box Hill, AU) from 2025 to 2026: 2 510(k) clearances. All are in product code NYV (Gastrointestinal Motility System, Capsule). Its devices cite 2 predicates, 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 Atmo Biosciences, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Atmo Biosciences, 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) Report