FDA applicant
Faceheart Corp.
FDA records 2 decisions for Faceheart Corp. (Grand Cayman, KY) from 2023 to 2025: 2 510(k) clearances. Most are in product codes QME (Software For Optical Camera-Based Measurement…) and BZQ (Monitor, Breathing Frequency). 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 Faceheart Corp.’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 2023.
Planning a device like Faceheart Corp.’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