Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ClearPoint Neuro, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
175 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 | 58 | 0 |
| DEN240023 | SmartFlow Neuro Cannula | ClearPoint Neuro, Inc. | 2024-11-13 | 175 | 0 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 | 161 | 0 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 | 107 | 0 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 | 107 | 0 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 | 107 | 0 |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023-11-27 | 60 | 0 |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | 2023-09-15 | 63 | 0 |
| K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022-09-16 | 28 | 0 |
| K213645 | ClearPoint Maestro Brain Model | ClearPoint Neuro, Inc. | 2022-08-08 | 263 | 0 |
| K214040 | ClearPoint Array System (version 1.1) | ClearPoint Neuro, Inc. | 2022-04-12 | 110 | 0 |
| K202575 | ClearPoint Array System | ClearPoint Neuro, Inc. | 2021-01-22 | 140 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda