510(k) · Cleared
Recalled · Class II · 2016Stealthstation Treatment Guidance Platform
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 Dec 12, 2000 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 280 devices in its family, counting itself, have a Class I recall. 279 later devices descend from it. It has been recalled once.
- Decided
- Dec 12, 2000
- Review
- 61 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 0
279 later devices descend from it, 1 citing it directly. 2 of the 280 devices in this family, counting this one, have a Class I recall.
- This deviceK003201 Stealthstation Treatment Guidance PlatformMedtronic Surgical Navigation Technologies · 2000
- 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 · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Showing 5 of 279 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 279 · See all- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003201 | Stealthstation Treatment Guidance Platform | Medtronic Surgical Navigation Technologies | 2000 | — |
| +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 |
| +4 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| +4 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 16 | 0 |
| 2016 | 16 | 0 |
| 2017 | 30 | 0 |
| 2018 | 19 | 0 |
| 2019 | 16 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 23 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 28 | 2 |
| 2026 | 22 | 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.
2 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? (279)
See all 2791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053610 | Abaris | 2006 | 278 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2016 | Class II | Z-1234-2016 | No Marketing Application | Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA. |
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.
What does this lineage say?
- Of its descendants, K053610 (Traxtal Technologies, Inc., 2006) has gone furthest, with 278 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 | — |
https://510kreport.com/device/K003201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K003201: Stealthstation Treatment Guidance Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003201
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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