FDA applicant
Adherium (Nz), Ltd.
FDA records 10 decisions for Adherium (Nz), Ltd. (Auckland, NZ) from 2017 to 2023: 10 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). Since 2016 its 510(k)s took a median of 178 days from receipt to decision, against 215 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 8 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 Adherium (Nz), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Adherium (Nz), 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