510(k) · Cleared
Recalled · Class I · 2020Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited
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 6, 2010 as substantially equivalent to K082060 (Brainlab AG, 2009) after a 267-day review. Its family tree reaches back 4 generations to 1999. 1 of the 19 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- May 6, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 8 ancestors in all. 10 later devices descend from it, 4 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 2 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 1 generation backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- This deviceK092467 Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri…Brainlab AG · 2010
- Descendant · cites it directly · 3 of its ownK192703 Cranial Image Guided Surgery System, Navigation Software Cranial…Brainlab AG · 2020
- Descendant · cites it directly · 3 of its ownK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- Descendant · 2 generations on · 1 of its ownK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
- Descendant · 2 generations on · 1 of its ownK193118 TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020
- Descendant · cites it directly · 0 of its ownK231897 NeuroAlign softwareMedivis, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG · 2020 · cites it directly3descendants
- K171661Scopis Extended Instrument Set EMScopis GmbH · 2017 · cites it directly3descendants
- K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG · 2023 · 2 generations on1descendant
- K193118TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020 · 2 generations on1descendant
- K231897NeuroAlign softwareMedivis, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −2 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −1 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| 0 (this device) | K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial… | Brainlab AG | 2010 | — |
| +1 | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation… | Brainlab AG | 2020 | — |
| +1 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| +2 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software… | Brainlab AG | 2023 | — |
| +2 | K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020 | — |
| +1 | K231897 | NeuroAlign software | Medivis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K082060 | Cranial Image Guided Surgery SystemSummary page 3…The information provided by BrainLAB in this 51 0 (k) application was found to be substantially equivalent with the predicate device Cranial Image Guided Surgery System (K082060). Compatibility of the Disposable Stylet to third-party catheters has been shown in performance testing. Therefore the force nec… | 2009 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2020 | Class II | Z-0056-2021 | Software design | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. |
| Apr 22, 2013 | Class I | Z-0598-2016 | Software in the Use Environment | Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K192703 (Brainlab AG, 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K082060.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Brainl-Al Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on patient image data being processed by the IGS workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a…
Read the full statement (151 words)
The Brainl-Al Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on patient image data being processed by the IGS workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-Ray, MR, MRA and ultrasound based model of the anatomy.
Example procedures include but are not limited to:
Cranial Procedures:
Tumor resections
Skull base surgery
Cranial biopsies
Craniotomies! Craniectonijes
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
Thalamotomies! Palliodotomies
ENT Procedures:
Transphenoidal procedures
Maximillary antrostornies
Ethmoidectomies
Spheno-idotormes/ sphenoid explorations
Turbinate resections
Frontal sinusotomnies
Intranasal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092467 · printed Nov 3, 2026
Cite this page
510(k) Report. “K092467: Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092467
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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