510(k) · Cleared
ClearedCranial Image Guided Surgery System
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 8, 2009 as substantially equivalent to K042391 (Brainlab AG, 2004) and 1 other predicate after a 291-day review. Its family tree reaches back 3 generations to 1999. 1 of the 24 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- May 8, 2009
- Review
- 291 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K983831 (1999). 7 ancestors in all. 16 later devices descend from it, 5 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 2 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 1 generation backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- This deviceK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- Descendant · cites it directly · 10 of its ownK092467 Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri…Brainlab AG · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK192703 Cranial Image Guided Surgery System, Navigation Software Cranial…Brainlab AG · 2020
- Descendant · 2 generations on · 3 of its ownK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- Descendant · cites it directly · 2 of its ownK100038 Disposable Reflective Marker SpheresBrainlab AG · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K092467 Vectorvision Cranial, Vectorvision Ent, Kolibri…cites it directly · 2010
Most influential descendants
Showing 5 of 16 · See all- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG · 2010 · cites it directly10descendants
- K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG · 2020 · 2 generations on3descendants
- K171661Scopis Extended Instrument Set EMScopis GmbH · 2017 · 2 generations on3descendants
- K100038Disposable Reflective Marker SpheresBrainlab AG · 2010 · cites it directly2descendants
- K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −1 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| 0 (this device) | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| +1 | K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial… | Brainlab AG | 2010 | Class I |
| +2 | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation… | Brainlab AG | 2020 | — |
| +2 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| +1 | K100038 | Disposable Reflective Marker Spheres | Brainlab AG | 2010 | 3 |
| +3 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software… | Brainlab AG | 2023 | — |
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 |
|---|---|---|
| 2010 | 2 | 1 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K042391 | Kolibri Image Guided Surgery SystemSummary page 1…ification Name: Image Guided Surgery System /Instrument, Stereotaxic Predicate Devices: Kolibri Image Guided Surgery System (K042391) VectorVision Cranial/ENT (K023651) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 1I Intended Use… | 2004 |
| * | K023651 | Vectorvision Cranial/EntSummary page 1…d Surgery System /Instrument, Stereotaxic Predicate Devices: Kolibri Image Guided Surgery System (K042391) VectorVision Cranial/ENT (K023651) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 1I Intended Use: This submission does not change t… | 2004 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential… Class I | 2010 | 10 |
| K100038 | Disposable Reflective Marker Spheres | 2010 | 2 |
| K172820 | Microscope Navigation Software | 2018 | 1 |
| K201752 | Disposable Pre-calibrated Suction | 2021 | 0 |
| K190250 | Microscope Navigation | 2019 | 0 |
Has anything in its family been recalled? (1 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.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K092467 (Brainlab AG, 2010) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K042391.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BrainLAB 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 BrainLAB 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/ Craniectomies
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
Thalamotomies/ Palliodotomies
ENT Procedures:
Transphenoidal procedures
Maximillary antrostomies
Ethmoidectomies
Spheno-idotomies/ sphenoid explorations
Turbinate resections
Frontal sinusotomies
Intranasal procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082060: Cranial Image Guided Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082060
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