510(k) · Cleared
Recalled · Class II · 2016Stealthstation System Goldeneye Micro-Magnetic Tracking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Surgical Navigation Technologies · HAW Neurological Stereotaxic Instrument
Cleared on Jun 12, 2000 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 752 devices in its family, counting itself, have a Class I recall. 751 later devices descend from it. It has been recalled 28 times.
- Decided
- Jun 12, 2000
- Review
- 52 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 28
- Predicates
- 0
751 later devices descend from it, 9 citing it directly. 6 of the 752 devices in this family, counting this one, have a Class I recall.
- This deviceK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000
- Descendant · cites it directly · 419 of its ownK014256 Kolibri Igs SystemsBrainlab AG · 2002
- Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 187 of its ownK042721 Kolibri SpineBrainlab AG · 2005
Showing 5 of 751 descendants. See all descendants
Descendants cleared per year
2002high 75 (2017) · low 1 (2002)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 751 · See all- K014256Kolibri Igs SystemsBrainlab AG · 2002 · cites it directly419descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K042721Kolibri SpineBrainlab AG · 2005 · 2 generations on187descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | — |
| +1 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| +1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +2 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +2 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 1 |
| 2008 | 8 | 0 |
| 2009 | 16 | 0 |
| 2010 | 11 | 1 |
| 2011 | 16 | 0 |
| 2012 | 17 | 0 |
| 2013 | 15 | 0 |
| 2014 | 30 | 0 |
| 2015 | 28 | 1 |
| 2016 | 39 | 0 |
| 2017 | 75 | 1 |
| 2018 | 32 | 0 |
| 2019 | 43 | 0 |
| 2020 | 67 | 0 |
| 2021 | 44 | 0 |
| 2022 | 53 | 0 |
| 2023 | 59 | 0 |
| 2024 | 60 | 0 |
| 2025 | 60 | 2 |
| 2026 | 60 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (751)
See all 7519 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014256 | Kolibri Igs Systems | 2002 | 419 |
| K053610 | Abaris | 2006 | 278 |
| K060903 | IG4 Image Guided System | 2006 | 47 |
| K133573 | Fiagon Navigation System | 2014 | 28 |
| K130608 | Quadcut | 2013 | 17 |
| K133665 | Malleable Suction Instruments | 2014 | 14 |
| K153247 | Fusion Compact Navigation System | 2016 | 4 |
| K141833 | Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer… | 2015 | 3 |
| K153555 | EM ENT Navigated Suctions | 2016 | 1 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2016 | Class II | Z-2317-2016 | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. |
| Jul 18, 2016 | Class II | Z-2319-2016 | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. |
| Apr 24, 2014 | Class II | Z-1581-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1600-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1582-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1587-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1601-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1591-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1584-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1578-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1580-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1595-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1594-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1593-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1596-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1590-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1589-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1598-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1592-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1585-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1579-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1602-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1583-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1599-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1588-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1597-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Apr 24, 2014 | Class II | Z-1586-2014 | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure… |
| Feb 1, 2006 | Not classified | Z-0718-06 | Other | Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery. |
The 5 latest of 28 recalls; the web page lists all.
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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 7 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K014256 (Brainlab AG, 2002) has gone furthest, with 419 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
2007high 15 (2007) · low 3 (2013)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
2007high 238 (2014) · low 66 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
2007high 28 (2010) · low 1 (2020)2026
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
2007high 6,062 (2019) · low 49 (2007)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 | — |
https://510kreport.com/device/K001284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001284
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026