510(k) · Cleared
ClearedVectorvision Cranial, Vectorvision Spinal, Vectorvision Ent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on May 21, 2001 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 of the 883 devices in its family, counting itself, have a Class I recall. 882 later devices descend from it.
- Decided
- May 21, 2001
- Review
- 182 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
882 later devices descend from it, 7 citing it directly. 12 of the 883 devices in this family, counting this one, have a Class I recall.
- This deviceK003589 Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntBrainlab AG · 2001
- Descendant · cites it directly · 419 of its ownK014256 Kolibri Igs SystemsBrainlab AG · 2002
- Descendant · cites it directly · 343 of its ownK020631 IPLANBrainlab AG · 2002
- Descendant · 2 generations on · 280 of its ownK040050 Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · cites it directly · 251 of its ownK012448 Vectorvision TraumaBrainlab AG · 2002
Showing 5 of 882 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 882 · See all- K014256Kolibri Igs SystemsBrainlab AG · 2002 · cites it directly419descendants
- K020631IPLANBrainlab AG · 2002 · cites it directly343descendants
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations on280descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · 3 generations on278descendants
- K012448Vectorvision TraumaBrainlab AG · 2002 · cites it directly251descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent | Brainlab AG | 2001 | — |
| +1 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| +1 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| +2 | K040050 | Instatrak System with Multiple Dataset Navigation, Model IT3500 | Ge Medical Systems Navigation and Visualization IN | 2004 | Class I |
| +3 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +1 | K012448 | Vectorvision Trauma | Brainlab AG | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 7 | 1 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 1 |
| 2008 | 10 | 0 |
| 2009 | 16 | 0 |
| 2010 | 12 | 1 |
| 2011 | 17 | 0 |
| 2012 | 17 | 0 |
| 2013 | 16 | 0 |
| 2014 | 32 | 0 |
| 2015 | 29 | 2 |
| 2016 | 33 | 0 |
| 2017 | 78 | 1 |
| 2018 | 40 | 1 |
| 2019 | 53 | 1 |
| 2020 | 63 | 1 |
| 2021 | 60 | 1 |
| 2022 | 58 | 0 |
| 2023 | 75 | 0 |
| 2024 | 69 | 0 |
| 2025 | 86 | 2 |
| 2026 | 80 | 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.
12 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? (882)
See all 8827 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 |
| K020631 | IPLAN | 2002 | 343 |
| K012448 | Vectorvision Trauma | 2002 | 251 |
| K023651 | Vectorvision Cranial/Ent | 2004 | 148 |
| K012564 | Modification to: Vectorvision Frameless Biopsy System | 2001 | 55 |
| K013428 | Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System | 2002 | 1 |
| K061479 | ARGOS | 2007 | 0 |
Has anything in its family been recalled? (12 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K151359ROSA BrainMedtech S.A · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 6 generations on · ◆ in the 2020 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 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 12; 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
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/K003589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003589
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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