FDA applicant
Atlantean
FDA records 2 decisions for Atlantean (Bonita Springs, FL) from 2010 to 2011: 2 510(k) clearances. Most are in product codes DQA (Oximeter) and CAF (Nebulizer (Direct Patient Interface)). 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 “Atlantean Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Atlantean’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Atlantean’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