# K142505: ClearPoint System

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Oct 21, 2015 after 411 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: 6 generations back to K031815 (2003). 10 ancestors in all.
10 later devices descend from it; 1 cites it directly.
4 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111073: Surgivision Inc. Clearpoint System, Surgi-Vision, Inc. (2011) Summary page 4.

## Most influential descendants
- K160434: ClearPoint System (2016), 9 descendants of its own
- K171257: ClearPoint System (2017), 8 descendants of its own
- K181195: ClearPoint System (2018), 7 descendants of its own
- K200079: ClearPoint System and Accessories (2020), 3 descendants of its own
- K222519: ClearPoint System (2022), 2 descendants of its own

## Indications for use
The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

Source page: https://510kreport.com/device/K142505
Methodology: https://510kreport.com/methodology