510(k) · Cleared
ClearedKolibri Igs Systems
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 Jul 19, 2002 as substantially equivalent to K001284 (Medtronic Surgical Navigation Technologies, 2000) and 2 other predicates after a 205-day review. Its family tree reaches back 1 generation to 1999. 4 of the 423 devices in its family, counting itself, have a Class I recall. 419 later devices descend from it.
- Decided
- Jul 19, 2002
- Review
- 205 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K983831 (1999). 3 ancestors in all. 419 later devices descend from it, 7 citing it directly. 4 of the 423 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK983831 VECTORVISION2Brainlab AG · 1999
- This deviceK014256 Kolibri Igs SystemsBrainlab AG · 2002
- Descendant · cites it directly · 187 of its ownK042721 Kolibri SpineBrainlab AG · 2005
- Descendant · cites it directly · 170 of its ownK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- Descendant · 2 generations on · 155 of its ownK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- Descendant · 2 generations on · 154 of its ownK060468 Vectorvision HipBrainlab AG · 2006
- Descendant · cites it directly · 134 of its ownK031770 CI TKR/UkrBrainlab AG · 2003
Showing 5 of 419 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 419 · See all- K042721Kolibri SpineBrainlab AG · 2005 · cites it directly187descendants
- K052213Navigation SW Hip 3.1 on CIBrainlab AG · 2005 · cites it directly170descendants
- K053159Vectorvision SpineBrainlab AG · 2006 · 2 generations on155descendants
- K060468Vectorvision HipBrainlab AG · 2006 · 2 generations on154descendants
- K031770CI TKR/UkrBrainlab AG · 2003 · cites it directly134descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| 0 (this device) | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| +1 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| +1 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| +2 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| +2 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| +1 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 1 |
| 2008 | 7 | 0 |
| 2009 | 11 | 0 |
| 2010 | 9 | 1 |
| 2011 | 12 | 0 |
| 2012 | 11 | 0 |
| 2013 | 10 | 0 |
| 2014 | 16 | 0 |
| 2015 | 8 | 1 |
| 2016 | 13 | 0 |
| 2017 | 39 | 1 |
| 2018 | 15 | 0 |
| 2019 | 27 | 0 |
| 2020 | 35 | 0 |
| 2021 | 21 | 0 |
| 2022 | 26 | 0 |
| 2023 | 37 | 0 |
| 2024 | 36 | 0 |
| 2025 | 35 | 0 |
| 2026 | 36 | 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? (4)
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 |
|---|---|---|---|
| * | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking SystemSummary page 2…ed by BrainLAB in this 510 (k) application was found fo b e substantially equivalent with the predicate devke StealthStationB System GoldeneyeT” Micro-Magnetic Tracking (K001284),t h e ReguIusTbA Navigator and the BrainLAB VectorVison (Cranial/ENT/Spinal) (K003589) / BrainLAB VectorVisionZ (K983831).… | 2000 |
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntSummary page 1…Medtronic Stealthstation@ System GoldeneyeTMMicro-Magnetic Tracking Option (K00128i.4) COMPASS Regulusm Navigator (K984229) EraEnLAB VectorVisian {Granial/ENT/Spinal) (K003589) ErainLAB VectarVisionZ (K98383 1) Device Classification Name: Instrumentr Stereotaxic Regulatory Class: Class I1 Indications fo… | 2001 |
| * | K983831 | VECTORVISION2Summary page 1…GoldeneyeTMMicro-Magnetic Tracking Option (K00128i.4) COMPASS Regulusm Navigator (K984229) EraEnLAB VectorVisian {Granial/ENT/Spinal) (K003589) ErainLAB VectarVisionZ (K98383 1) Device Classification Name: Instrumentr Stereotaxic Regulatory Class: Class I1 Indications for use: The BrainLAB Kolibri IGS Sy… | 1999 |
| * | — | COMPASS Regulus Navigator Named without a submission number |
What descends from it? (419)
See all 4197 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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations on · ◆ in the 2007 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
- K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 | — |
What is it indicated for?
The BrainLAB Kolibri IGS System is intended to be an intraoperative 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 a patient's preoperative diagnostic image data set being processed by the Kolibit computer workstation. The system is indicated for any medical condition in which the use of…
Read the full statement (165 words)
The BrainLAB Kolibri IGS System is intended to be an intraoperative 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 a patient's preoperative diagnostic image data set being processed by the Kolibit computer 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, X-ray or MR based model of the anatomy.
Example image guided cranial surgery procedures include but are not fimited to:
I . Tumor resections
2. Sku-,ullbase surgery
3. Cranial biopsies
4. Craniotomies/Cmniectornies;
Example image guided ENT surgery procedures include, but are not limited to:
1. Transphenoidal procedures
2. Maxillary antrostomies
3. Ethmoidectomies,
4. SphenoidotomiesJsphenoid explorations,
5. Turbinate resections
6. Frontal sinusotomies
7. Intranasal procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014256 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014256: Kolibri Igs Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014256
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026