# ClearPoint Neuro, Inc.

- Location (FDA's records): Solana Beach, CA
- FDA decisions: 12 (2021–2025): 11 510(k) clearances and 1 De Novo grant
- Product codes: HAW (10), QIH (1), SDG (1)
- 510(k) review time since 2016: median 107 days, against 128 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 15 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Image-Guided Neurologics, Inc.: 3 (https://510kreport.com/company/image-guided-neurologics)
- Mri Interventions, Inc.: 2 (https://510kreport.com/company/mri-interventions)
- Fred Haer Company, Inc.: 1 (https://510kreport.com/company/fred-haer)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Cortechs Labs, Inc.: 1 (https://510kreport.com/company/cortechs-labs)

## Its most-cited devices
- K202575: ClearPoint Array System (2021), cited by 2
- K222519: ClearPoint System (2022), cited by 2
- K233243: ClearPoint System (Software Version 2.2) (2023), cited by 1
- K213645: ClearPoint Maestro Brain Model (2022), cited by 1
- K214040: ClearPoint Array System (version 1.1) (2022), cited by 1

## Recent decisions
- K243657: ClearPoint System (Software Version 3.0) (Jan 24, 2025)
- DEN240023: SmartFlow Neuro Cannula (Nov 13, 2024)
- K233703: Bone Anchor (NGS-BA-01) (Apr 26, 2024)
- K233144: ClearPoint Bone Screw Fiducials (Jan 12, 2024)
- K233155: ClearPointer Optical Navigation Wand (Jan 12, 2024)
- K233141: SmartFrame OR (Jan 12, 2024)
- K233243: ClearPoint System (Software Version 2.2) (Nov 27, 2023)
- K232102: ClearPoint Array System (Version 1.2) (Sep 15, 2023)

Source page: https://510kreport.com/company/clearpoint-neuro