510(k) · Cleared
ClearedMicroscope Navigation Software
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 Mar 1, 2018 as substantially equivalent to K082060 (Brainlab AG, 2009) after a 164-day review. Its family tree reaches back 4 generations to 1999. 1 later device descends from it.
- Decided
- Mar 1, 2018
- Review
- 164 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK172820 Microscope Navigation SoftwareBrainlab AG · 2018
- Descendant · cites it directly · 0 of its ownK190250 Microscope NavigationBrainlab AG · 2019
Most influential descendants
Showing 1 of 1 · See all- K190250Microscope NavigationBrainlab AG · 2019 · 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) | K172820 | Microscope Navigation Software | Brainlab AG | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 4…Frameless Stereotaxic Navigation System Classification name: Neurological Stereotaxic Instrument (21 CFR 882.4560, Product Code HAW) Predicate Device: K082060 VECTORVISION CRANIAL Regulatory Class: Class II Regulation Number: 882.4560 Intended use: The Brainlab Navig… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190250 | Microscope Navigation | 2019 | 0 |
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 19 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K190250 (Brainlab AG, 2019) has gone furthest, with 0 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. 2018, 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/K172820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172820: Microscope Navigation Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172820
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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