510(k) · Cleared
ClearedMicroscope Navigation
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 Sep 6, 2019 as substantially equivalent to K172820 (Brainlab AG, 2018) and 1 other predicate after a 211-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Sep 6, 2019
- Review
- 211 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K983831 (1999). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 2 generations backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- 1 generation backK172820 Microscope Navigation SoftwareBrainlab AG · 2018
- This deviceK190250 Microscope NavigationBrainlab AG · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −2 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| −1 | K172820 | Microscope Navigation Software | Brainlab AG | 2018 | — |
| 0 (this device) | K190250 | Microscope Navigation | Brainlab AG | 2019 | — |
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 |
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.
Planning a device in HAW? 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 |
|---|---|---|---|
| * | K172820 | Microscope Navigation SoftwareSummary page 4…Frameless Stereotaxic Navigation System Classification name: Neurological Stereotaxic Instrument (21 CFR 882.4560, Product Code HAW) Predicate Device: K172820 Microscope Navigation Regulatory Class: Class II Regulation Number: 882.4560 Intended use: The Brainlab Navi… | 2018 |
| * | K082060 | Cranial Image Guided Surgery SystemSummary page 5…The Microscope Navigation does not provide its own registration. Reason for 510(k) Microscope Navigation Version 1.0 has been cleared under K172820, with K082060 submission: VECTORVISION CRANIAL as predicate device. Compared to its predicate device, M… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Navigation System – Microscope Navigation Software is a software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g., video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the navigation workstation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190250: Microscope Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190250
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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