510(k) · Cleared
ClearedClearPoint System (Software Version 3.0)
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 Jan 24, 2025 as substantially equivalent to K233243 (ClearPoint Neuro, Inc., 2023) and 2 other predicates after a 58-day review. Its family tree reaches back 12 generations to 2003. 8 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 24, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K031815 (2003). 25 ancestors in all, the oldest K992927 (1999). No later device cites it as a predicate yet. 8 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 8 generations between
- 3 generations backK181195 ClearPoint SystemMri Interventions, Inc. · 2018
- 2 generations backK222519 ClearPoint SystemClearPoint Neuro, Inc. · 2022
- 1 generation backK233243 ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. · 2023
- This deviceK243657 ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 11 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 10 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 9 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- 8 generations backK100836 Clearpoint SystemSurgivision, Inc. · 2010
- 7 generations backK111073 Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 2011
- 6 generations backK142505 ClearPoint SystemMri Interventions, Inc. · 2015
- 5 generations backK160434 ClearPoint SystemMri Interventions, Inc. · 2016
- 4 generations backK171257 ClearPoint SystemMri Interventions, Inc. · 2017
- 3 generations backK181195 ClearPoint SystemMri Interventions, Inc. · 2018
- 2 generations backK222519 ClearPoint SystemClearPoint Neuro, Inc. · 2022
- 1 generation backK233243 ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. · 2023
- This deviceK243657 ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −11 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −10 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −9 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| −8 | K100836 | Clearpoint System | Surgivision, Inc. | 2010 | — |
| −7 | K111073 | Surgivision Inc. Clearpoint System | Surgi-Vision, Inc. | 2011 | — |
| −6 | K142505 | ClearPoint System | Mri Interventions, Inc. | 2015 | — |
| −5 | K160434 | ClearPoint System | Mri Interventions, Inc. | 2016 | — |
| −4 | K171257 | ClearPoint System | Mri Interventions, Inc. | 2017 | — |
| −3 | K181195 | ClearPoint System | Mri Interventions, Inc. | 2018 | — |
| −2 | K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022 | — |
| −1 | K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023 | — |
| 0 (this device) | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 1 |
| 2006 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2019 | 1 | 1 |
| 2022 | 2 | 1 |
| 2023 | 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.
8 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? (3)
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 |
|---|---|---|---|
| * | K233243 | ClearPoint System (Software Version 2.2)Summary page 5…Regulatory Class: Class II Product Code HAW 3. PREDICATE DEVICES • ClearPoint Software Version 2.2 K233243 • ClearPoint Software Version 2.1 K222519 4. DEVICE DESCRIPTION The updated ClearPoint Software V… | 2023 |
| * | K222519 | ClearPoint SystemSummary page 5…HAW 3. PREDICATE DEVICES • ClearPoint Software Version 2.2 K233243 • ClearPoint Software Version 2.1 K222519 4. DEVICE DESCRIPTION The updated ClearPoint Software Version 3.0 introduces modifications to support a new clinical… | 2022 |
| * | K231976 | StealthStation Cranial Software, v3.1.5 (9735585)Summary page 8…stantially equivalent to the previously cleared ClearPoint System (Version 2.2) (K233243) and the reference device StealthStation Cranial Software, v3.1.5 (K231976). The subject device’s hardware is identical in design and technological characteristics to the predicate device. The diff… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (8 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.
- K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022 · 2 generations back · ◆ in the 2022 ancestors bar of FIG. 12 Class I recalls
- K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Medtronic Navigation, Inc. · 2019 · 3 generations back · ◆ in the 2019 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- 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
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 25 ancestors have a recall of any class; 8 have a Class I recall.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 an operating room environment and in conjunction with MR and/or CT 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…
Read the full statement (127 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 an operating room environment and in conjunction with MR and/or CT 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) (asleep or awake) lead placement. When used in an MRI environment, 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/K243657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243657: ClearPoint System (Software Version 3.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243657
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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