510(k) · Cleared
ClearedRegulus Navigator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compass Intl., Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Aug 19, 1997 as substantially equivalent to K935456 (Compass Intl., Inc., 1995) and 2 other predicates after a 300-day review. Its family tree reaches back 2 generations to 1994. 66 later devices descend from it.
- Decided
- Aug 19, 1997
- Review
- 300 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911783 (1994). 6 ancestors in all, the oldest K871046 (1987). 66 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 1 generation backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- This deviceK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- Descendant · cites it directly · 36 of its ownK981315 NavitrackOrthosoft, Inc. · 1998
- Descendant · 2 generations on · 35 of its ownK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- Descendant · 3 generations on · 34 of its ownK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- Descendant · 3 generations on · 33 of its ownK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- Descendant · 3 generations on · 32 of its ownK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K981315NavitrackOrthosoft, Inc. · 1998 · cites it directly36descendants
- K033413Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004 · 2 generations on35descendants
- K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005 · 3 generations on34descendants
- K063607Spineassist SystemMazor Surgical Technologies, Ltd. · 2007 · 3 generations on33descendants
- K073467Spineassist SystemMazor Surgical Technologies, Ltd. · 2008 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −1 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| 0 (this device) | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| +1 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| +2 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| +3 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| +3 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| +3 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 1 | 0 |
| 2020 | 11 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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.
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? (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 |
|---|---|---|---|
| * | K935456 | Regulus Measurement UnitSummary page 1…AW C. Identification of Predicate Devices The Regulus Navigator (RN) as described in this submission is substantially equivalent to the Regulus Measurement Unit (RMU), K935456, which is currently manufactured and marketed by COMPASS International, Inc. The RN also incorporates some of the features that w… | 1995 |
| * | K871046 | Compass Stereotactic Positioning SystemSummary page 1…and marketed by COMPASS International, Inc. The RN also incorporates some of the features that were previously provided by the COMPASS Stereotactic Positioning System, K871046. The RN incorporates components that are substantially equivalent in function and accuracy to other legally marketed devices inc… | 1987 |
| * | K960714 | Isg Viewing WandSummary page 1…The RN incorporates components that are substantially equivalent in function and accuracy to other legally marketed devices including the ISG Family of Viewing Wands, K960714. REGULUS NAVIGATOR 10(k) Summa f Safety and Effectiven D. Description of the Device 1. Description: The Regulus… | 1996 |
What descends from it? (66)
See all 662 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K981315 (Orthosoft, Inc., 1998) has gone furthest, with 36 descendants of its own.
- 1 other device also cites its predicate K935456.
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?
Intraoperative Guidance Device to Localize a Surgical Field for
Intra/Extracranial .. Usage
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964229 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964229: Regulus Navigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964229
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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