FDA applicant
Brightheart
FDA records 5 decisions for Brightheart (Paris, FR) from 2024 to 2025: 5 510(k) clearances. Most are in product codes POK (Computer-Assisted Diagnostic Software For…) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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 Brightheart’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Brightheart’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