FDA applicant
ClearPoint Neuro, Inc.
FDA records 12 decisions for ClearPoint Neuro, Inc. (Solana Beach, CA) from 2021 to 2025: 11 510(k) clearances and 1 De Novo grant. Most are in product codes HAW (Neurological Stereotaxic Instrument) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 7 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 ClearPoint Neuro, 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 2021.
Planning a device like ClearPoint Neuro, 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