510(k) · Cleared
ClearedClearPoint System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Interventions, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Mar 17, 2016 as substantially equivalent to K142505 (Mri Interventions, Inc., 2015) after a 30-day review. Its family tree reaches back 7 generations to 2003. 4 of the 21 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Mar 17, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K031815 (2003). 11 ancestors in all, the oldest K001796 (2000). 9 later devices descend from it, 1 citing it directly. 4 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 6 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 5 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 4 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- 3 generations backK100836 Clearpoint SystemSurgivision, Inc. · 2010
- 2 generations backK111073 Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 2011
- 1 generation backK142505 ClearPoint SystemMri Interventions, Inc. · 2015
- This deviceK160434 ClearPoint SystemMri Interventions, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK171257 ClearPoint SystemMri Interventions, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK181195 ClearPoint SystemMri Interventions, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK200079 ClearPoint System and AccessoriesMri Interventions, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK222519 ClearPoint SystemClearPoint Neuro, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK202575 ClearPoint Array SystemClearPoint Neuro, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K171257ClearPoint SystemMri Interventions, Inc. · 2017 · cites it directly8descendants
- K181195ClearPoint SystemMri Interventions, Inc. · 2018 · 2 generations on7descendants
- K200079ClearPoint System and AccessoriesMri Interventions, Inc. · 2020 · 3 generations on3descendants
- K222519ClearPoint SystemClearPoint Neuro, Inc. · 2022 · 3 generations on2descendants
- K202575ClearPoint Array SystemClearPoint Neuro, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −6 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −5 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −4 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| −3 | K100836 | Clearpoint System | Surgivision, Inc. | 2010 | — |
| −2 | K111073 | Surgivision Inc. Clearpoint System | Surgi-Vision, Inc. | 2011 | — |
| −1 | K142505 | ClearPoint System | Mri Interventions, Inc. | 2015 | — |
| 0 (this device) | K160434 | ClearPoint System | Mri Interventions, Inc. | 2016 | — |
| +1 | K171257 | ClearPoint System | Mri Interventions, Inc. | 2017 | — |
| +2 | K181195 | ClearPoint System | Mri Interventions, Inc. | 2018 | — |
| +3 | K200079 | ClearPoint System and Accessories | Mri Interventions, Inc. | 2020 | — |
| +3 | K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022 | — |
| +4 | K202575 | ClearPoint Array System | ClearPoint Neuro, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K142505 | ClearPoint SystemSummary page 4…Regulation Number: 21 C.F.R. § 882.4560 Product Code: HAW, ORR 3. Predicate Device: MRII ClearPoint System, K142505 4. Device Description: The ClearPoint System is comprised of a workstation laptop with software, the… | 2015 |
| † | K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | 2015 |
| † | K100836 | Clearpoint System | 2010 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171257 | ClearPoint System | 2017 | 8 |
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 · 4 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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 5 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 11 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K171257 (Mri Interventions, Inc., 2017) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160434: ClearPoint System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160434
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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