FDA applicant
Medeia, Inc.
FDA records 4 decisions for Medeia, Inc. (Santa Barbara, CA) from 2015 to 2023: 4 510(k) clearances. Most are in product codes GZO (Device, Galvanic Skin Response Measurement) and JOM (Plethysmograph, Photoelectric, Pneumatic Or…). Its devices cite 8 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 Medeia, Inc.’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 2015.
Planning a device like Medeia, Inc.’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