FDA applicant
Cognita Labs, LLC
FDA records 2 decisions for Cognita Labs, LLC (Santa Ana, CA) from 2019 to 2020: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and PNV (Impedance Measuring Device Utilizing…). Its devices cite 3 predicates, 0 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 Cognita Labs, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Cognita Labs, LLC’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