ClearPoint Neuro, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “ClearPoint Neuro, Inc.” (first 2021, latest 2025), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 107 days. Since 2017 the median was 107 days, against 140 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 140 |
| 2022 | 3 | 110 |
| 2023 | 2 | 62 |
| 2024 | 4 | 107 |
| 2025 | 1 | 58 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ClearPoint Neuro, Inc. took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 10 | 10 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
| SDG | Brain Intraparenchymal Infusion Cannula | 1 | 0 |
Review panels
Most recent ClearPoint Neuro, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243657 | ClearPoint System (Software Version 3.0) | HAW | 2025-01-24 | 58 |
| K233703 | Bone Anchor (NGS-BA-01) | HAW | 2024-04-26 | 161 |
| K233155 | ClearPointer Optical Navigation Wand | HAW | 2024-01-12 | 107 |
| K233144 | ClearPoint Bone Screw Fiducials | HAW | 2024-01-12 | 107 |
| K233141 | SmartFrame OR | HAW | 2024-01-12 | 107 |
| K233243 | ClearPoint System (Software Version 2.2) | HAW | 2023-11-27 | 60 |
| K232102 | ClearPoint Array System (Version 1.2) | HAW | 2023-09-15 | 63 |
| K222519 | ClearPoint System | HAW | 2022-09-16 | 28 |
| K213645 | ClearPoint Maestro Brain Model | QIH | 2022-08-08 | 263 |
| K214040 | ClearPoint Array System (version 1.1) | HAW | 2022-04-12 | 110 |
1 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240023 | De Novo | Brain Intraparenchymal Infusion Cannula | 2024-11-13 |
Recalls
openFDA lists no recalls under a recalling firm named ClearPoint Neuro, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
ClearPoint Neuro, Inc. (CLPT): EDGAR filings, CIK 1285550. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under ClearPoint Neuro, Inc.?
FDA lists 11 510(k) clearances under the applicant name “ClearPoint Neuro, Inc.” (first 2021, latest 2025), plus 1 De Novo decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by ClearPoint Neuro, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ClearPoint Neuro, Inc. is 107 days. Since 2017: 107 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ClearPoint Neuro, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 10); QIH (Automated Radiological Image Processing Software, 1); SDG (Brain Intraparenchymal Infusion Cannula, 1).
Next steps
- See all 11 ClearPoint Neuro, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, ClearPoint Neuro, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.