510(k) · Cleared
ClearedStealthStation Cranial Software v1.3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 3, 2020 as substantially equivalent to K162309 (Medtronic Navigation, Inc., 2017) after a 33-day review. Its family tree reaches back 4 generations to 2005. 4 of the 15 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Jun 3, 2020
- Review
- 33 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050438 (2005). 6 ancestors in all, the oldest K992927 (1999). 8 later devices descend from it, 2 citing it directly. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 3 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 2 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 1 generation backK162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Recalled (Class I)
- This deviceK201175 StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK203639 StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK212397 StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK212194 Stryker Q Guidance System with Cranial Guidance Software…Stryker Corporation · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK213989 Cranial EM SystemBrainlab AG · 2022
- Descendant · 3 generations on · 0 of its ownK253379 Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc. · 2021 · cites it directly5descendants
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 2 generations on4descendants
- K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation · 2023 · 3 generations on1descendant
- K213989Cranial EM SystemBrainlab AG · 2022 · cites it directly1descendant
- K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −3 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −2 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −1 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017 | Class I |
| 0 (this device) | K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | — |
| +1 | K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | 2021 | — |
| +2 | K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | 2021 | Class I |
| +3 | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker… | Stryker Corporation | 2023 | 2 |
| +1 | K213989 | Cranial EM System | Brainlab AG | 2022 | — |
| +3 | K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareSummary page 4…CFR 882.4560) IV. Classification: Class II, Stereotaxic Instrument V. Product Codes: HAW VI. Predicate Device 510(k): K162309 Device name: StealthStation S8 Cranial Software v1.0.0 Manufacturer: Medtronic Navigation, Inc.… | 2017 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K203639 (Medtronic Navigation, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K162309.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use 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, can be identified relative to images of the anatomy. This can include, but is not limited to…
Read the full statement (105 words)
The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use 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, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
• Tumor resections
• General ventricular catheter placement
• Pediatric ventricular catheter placement
• Depth electrode, lead, and probe placement
• Cranial biopsies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201175 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201175: StealthStation Cranial Software v1.3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201175
Report an extraction error
Are you the manufacturer?
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