510(k) · Cleared
ClearedClearPoint System (Software Version 2.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearPoint Neuro, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Nov 27, 2023 as substantially equivalent to K222519 (ClearPoint Neuro, Inc., 2022) and 1 other predicate after a 60-day review. Its family tree reaches back 11 generations to 2003. 4 of the 19 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 27, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K031815 (2003). 17 ancestors in all, the oldest K001796 (2000). 1 later device descends from it, 1 citing it directly. 4 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 7 generations between
- 3 generations backK171257 ClearPoint SystemMri Interventions, Inc. · 2017
- 2 generations backK181195 ClearPoint SystemMri Interventions, Inc. · 2018
- 1 generation backK222519 ClearPoint SystemClearPoint Neuro, Inc. · 2022
- This deviceK233243 ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243657 ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 10 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 9 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 8 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- 7 generations backK100836 Clearpoint SystemSurgivision, Inc. · 2010
- 6 generations backK111073 Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 2011
- 5 generations backK142505 ClearPoint SystemMri Interventions, Inc. · 2015
- 4 generations backK160434 ClearPoint SystemMri Interventions, Inc. · 2016
- 3 generations backK171257 ClearPoint SystemMri Interventions, Inc. · 2017
- 2 generations backK181195 ClearPoint SystemMri Interventions, Inc. · 2018
- 1 generation backK222519 ClearPoint SystemClearPoint Neuro, Inc. · 2022
- This deviceK233243 ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −10 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −9 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −8 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| −7 | K100836 | Clearpoint System | Surgivision, Inc. | 2010 | — |
| −6 | K111073 | Surgivision Inc. Clearpoint System | Surgi-Vision, Inc. | 2011 | — |
| −5 | K142505 | ClearPoint System | Mri Interventions, Inc. | 2015 | — |
| −4 | K160434 | ClearPoint System | Mri Interventions, Inc. | 2016 | — |
| −3 | K171257 | ClearPoint System | Mri Interventions, Inc. | 2017 | — |
| −2 | K181195 | ClearPoint System | Mri Interventions, Inc. | 2018 | — |
| −1 | K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022 | — |
| 0 (this device) | K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023 | — |
| +1 | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 1 |
| 2006 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222519 | ClearPoint SystemSummary page 5…ClearPoint Neuro, Inc. Predicate Device Common Name: Neurological Stereotactic Instrument Predicate Device Premarket Notification # K222519 Predicate Device Classification & Name Neurological Stereotaxic Instrument,… | 2022 |
| * | K213645 | ClearPoint Maestro Brain ModelSummary page 5…Common Name: System, Image Processing, Radiological Predicate Device Premarket Notification # K213645 Predicate Device Classification & Name Medical Imaging Management and… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243657 | ClearPoint System (Software Version 3.0) | 2025 | 0 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 9 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 9 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 9 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 17 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K243657 (ClearPoint Neuro, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K222519.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The ClearPoint System 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. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization and quantification of segmentable brain structures from a set of loaded MR images. The…
Read the full statement (115 words)
The ClearPoint System 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. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization and quantification of segmentable brain structures from a set of loaded MR images. 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233243: ClearPoint System (Software Version 2.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233243
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026