510(k) · Cleared
Recalled · Class II · 2014Fluoronav Module for the Stealthstation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Navigation Technologies, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 22, 1999 after a 90-day review. The FDA summary names its predicate without a number. 4 of the 451 devices in its family, counting itself, have a Class I recall. 450 later devices descend from it. It has been recalled 29 times.
- Decided
- Apr 22, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 29
- Predicates
- 0
450 later devices descend from it, 6 citing it directly. 4 of the 451 devices in this family, counting this one, have a Class I recall.
- This deviceK990214 Fluoronav Module for the Stealthstation SystemSurgical Navigation Technologies, Inc. · 1999
- Descendant · cites it directly · 294 of its ownK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 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 · cites it directly · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
Showing 5 of 450 descendants. See all descendants
Descendants cleared per year
1999high 46 (2025) · low 0 (2007)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 450 · See all- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · cites it directly294descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · cites it directly151descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990214 | Fluoronav Module for the Stealthstation System | Surgical Navigation Technologies, Inc. | 1999 | — |
| +1 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| +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 |
| +1 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 1 |
| 2001 | 1 | 0 |
| 2002 | 1 | 1 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 12 | 0 |
| 2015 | 23 | 0 |
| 2016 | 21 | 0 |
| 2017 | 41 | 0 |
| 2018 | 22 | 0 |
| 2019 | 26 | 0 |
| 2020 | 39 | 0 |
| 2021 | 34 | 0 |
| 2022 | 37 | 0 |
| 2023 | 38 | 0 |
| 2024 | 33 | 0 |
| 2025 | 46 | 2 |
| 2026 | 33 | 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 |
|---|---|---|---|
| * | — | original StealthStation® System Named without a submission number |
What descends from it? (450)
See all 4506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 Class I | 2000 | 294 |
| K053610 | Abaris | 2006 | 278 |
| K013025 | Modification to Flourolab Plus | 2001 | 151 |
| K080624 | Navstationirad Emt, Version 1.1 | 2008 | 63 |
| K050651 | Medtronic Orthopaedic Trauma Application | 2005 | 1 |
| K993673 | SNN Fluoro Navigation System | 1999 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 6, 2012 | Not classified | Z-1189-2012 | Device Design | When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra. |
| Feb 6, 2012 | Not classified | Z-1190-2012 | Device Design | When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra. |
| Jan 20, 2011 | Not classified | Z-0001-2012 | Labeling design | Distal end of tactile probe may break off during use. |
| Jan 20, 2011 | Not classified | Z-0002-2012 | Labeling design | Distal end of tactile probe may break off during use. |
The 5 latest of 29 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.
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 12 Class I recalls
- K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · 2 generations on · ◆ in the 2002 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
What does this lineage say?
- Of its descendants, K994270 (Visualization Technology, Inc., 2000) has gone furthest, with 294 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 | — |
What is it indicated for?
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.
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/K990214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990214: Fluoronav Module for the Stealthstation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990214
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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