FDA applicant
Mindset Medical, Inc.
FDA records 2 decisions for Mindset Medical, Inc. (Phoenix, AZ) from 2024 to 2025: 2 510(k) clearances. All are in product code QME (Software For Optical Camera-Based Measurement…). Its devices cite 2 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 Mindset Medical, Inc.’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 2024.
Planning a device like Mindset Medical, 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