510(k) · Cleared
ClearedNavigus II MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image-Guided Neurologics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Oct 22, 2001 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Oct 22, 2001
- Review
- 69 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK012719 Navigus II MRImage-Guided Neurologics, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK100836 Clearpoint SystemSurgivision, Inc. · 2010
- Descendant · 2 generations on · 11 of its ownK111073 Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 2011
- Descendant · 3 generations on · 10 of its ownK142505 ClearPoint SystemMri Interventions, Inc. · 2015
- Descendant · 4 generations on · 9 of its ownK160434 ClearPoint SystemMri Interventions, Inc. · 2016
- Descendant · 5 generations on · 8 of its ownK171257 ClearPoint SystemMri Interventions, Inc. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100836Clearpoint SystemSurgivision, Inc. · 2010 · cites it directly12descendants
- K111073Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 2011 · 2 generations on11descendants
- K142505ClearPoint SystemMri Interventions, Inc. · 2015 · 3 generations on10descendants
- K160434ClearPoint SystemMri Interventions, Inc. · 2016 · 4 generations on9descendants
- K171257ClearPoint SystemMri Interventions, Inc. · 2017 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012719 | Navigus II MR | Image-Guided Neurologics, Inc. | 2001 | — |
| +1 | K100836 | Clearpoint System | Surgivision, Inc. | 2010 | — |
| +2 | K111073 | Surgivision Inc. Clearpoint System | Surgi-Vision, Inc. | 2011 | — |
| +3 | K142505 | ClearPoint System | Mri Interventions, Inc. | 2015 | — |
| +4 | K160434 | ClearPoint System | Mri Interventions, Inc. | 2016 | — |
| +5 | K171257 | ClearPoint System | Mri Interventions, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100836 | Clearpoint System | 2010 | 12 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100836 (Surgivision, Inc., 2010) has gone furthest, with 12 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.
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?
Intended Use: The NAVIGUS II MR Trajectory Guide 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 Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction.
This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012719: Navigus II MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012719
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026