# K232102: ClearPoint Array System (Version 1.2)

- Pathway: 510(k) (Special)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Sep 15, 2023 after 63 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K031815 (2003). 17 ancestors in all.
No later device cites it as a predicate yet.
4 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214040: ClearPoint Array System (version 1.1), ClearPoint Neuro, Inc. (2022) Summary page 4.
- K202575: ClearPoint Array System, ClearPoint Neuro, Inc. (2021) Summary page 4.

## Indications for use
The ClearPoint Array System (Version 1.2) is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint Array System (Version 1.2) is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.

Source page: https://510kreport.com/device/K232102
Methodology: https://510kreport.com/methodology